GET TO KNOW OUR TEAM.
Management
Tanja Reischl-Stenske
Tanja is a pharmacist and has been working in the healthcare industry in leadership and executive roles for the past 20 years.
She covers the fields of Product Development, Regulatory Affairs, Production, Supply Chain Optimisation, Tech Transfers, Quality Management / Qualified Person, Product Compliance and Pharmacovigilance.
Tanja has long term experience in managing complex intercultural projects. She has been extraordinary successful in the area of supply chain optimisation / cost reduction, regulatory compliance, and in the localisation of production in Russia.
Christian Stenske
Christian has been working in leadership and executive roles within the healthcare industry for more than 20 years.
He covers the fields of strategy, marketing, sales, supply chain management (including supplier selection and negotiation,), partnering and partner networks, business development, finance, and human resources.
Christian’s expertise lies in the transformation of companies. Therefore, he strategically aligns them and takes care of a state of the art implementation based on a structured project plan. His main focus: Increasing the value for company owners with a healthy mixture of short term success in the context of a long term strategy.
Cristina Almeida
Cristina combines a degree in Pharmaceutical Sciences with a post-graduate specialization course in Clinical Analysis and a PhD in the field of Analytical Chemistry.
In addition, she’s been awarded the title of Specialist in the Pharmaceutical Industry, which allows her to assume the role and responsibilities of Technical Director and Qualified Person.
With professional experience ranging from distribution and manufacturing to holding a position as professor for more than 20 years, she’s originally been supporting us in Quality Management and as a skilled auditor, before also taking on the lead of our Porto site as Managing Director of THE FORCE Portugal.
Ahmet Sahin
In addition to a B.A. in Economics and an MBA, Ahmet has more than 20 years of international business experience, from manufacturing and sourcing to logistics. Throughout his career, he has been to over 50 countries for business, and managed a variety of teams across the world.
Not least thanks to his special training and official certification for global technology implementation, his background also includes the implementation and maintenance of supply chain systems and modules – as well as first-hand experience in negotiating, tendering, and managing contracts with companies in the technology sector.
At THE FORCE, Ahmet has taken on the responsibility of Managing Director of THE FORCE Türkiye and leading our Software Development team to create AI integrated business software solutions.
Robert P. Picard
Robert is an experienced senior consultant with over 30 years of professional experience in leading positions across the pharmaceutical, biotech, and medical device industries.
His specialties range from new start-up support to shakedowns to process tech-transfers and restarts, while his areas of expertise also include solution implementation, cost reduction, and change management – and not least the continuous improvement of businesses. In all of this, Robert’s strength is in delivering on time and below budget.
At THE FORCE, he not only applies his extensive background in, among other things, business transformation, clean rooms, construction management, and procurement, but also uses his experience to take on the role as Managing Director of THE FORCE North America.
Sandra Berzina
Sandra combines her education as a pharmacist with an MBA, resulting in more than 30 years of professional experience in pharma management so far.
Over the course of her career, she’s taken on various leading and management positions in different sectors within the pharmaceutical field. Her background stretches from acting as pharma inspector to positions in marketing, sales and product management in several international companies in medicines, medical devices, and food supplements alike.
Not least due to acting as vice president of the Pharmacist Society of Latvia and 4 years as vice President of EuroPharm Forum, her specialties also include event organisation, a professional project implementation on country level, and people management.
Moto Dohi
Moto has more than 15 years of experience in the pharmaceutical industry, with his specialties lying in product development, strategic leadership, and corporate transformation. During this time, he has successfully led cross-functional teams to launch innovative pharmaceutical products, including oncology drugs and medical devices.
His unique expertise in bridging European and Japanese markets make him an invaluable resource for German and other European companies seeking to establish or expand their presence in Japan.
At THE FORCE, Moto focuses on bringing his deep understanding of both pharmaceutical technical and business development as well as of intercultural business practices to our clients in Japan, ensuring they effectively achieve their goals.
Quality Management
Dr. Harald Keller
Harald is a biologist with over 14 years of practical experience in the life sciences and healthcare industry. Scientific expertise, knowledge of the GMP/GDP legislation, and strong analytical thinking skills paired with some drops of pragmatism and creativity are his formula for effectively handling quality related topics.
As an experienced auditor, he has conducted more than 100 audits and managed numerous authority inspections. He has successfully supported customers from a quality side in the set-up or extension of quality systems to achieve their required licenses, to eliminate backlogs, and to improve processes.
Further fields of Harald’s expertise include supplier qualification, GDP topics, technical agreements, and project management. Not least, he’s taken on the roles of Head of Quality, Head of Production, or RP GDP in interim management for several customers.
Jasmin Ritz
Jasmin is a chemist with a master’s degree in Process Analysis & Technology Management. During more than 7 years in quality management in the medical device and pharmaceutical industry, she has gained experience in setting up and improving quality management systems, GMP-/GDP-troubleshooting, supervising external audits and inspections as well as in conducting internal and external audits as auditor.
At THE FORCE, she combines a straightforward and pragmatic approach with in-depth knowledge of GMP- and GDP-legislation. With this, she has assumed a variety of roles on behalf of our customers, including Head of Quality, RP GDP, RP for medicinal cannabis, and project manager.
In addition, Jasmin is recognized by her very analytical way of thinking, which she has already successfully applied to various projects, such as supporting pharmaceutical development in CMC-related topics, setting-up a cleaning validation concept, and acting as project manager for realization of IMP-production.
Julia Zaitseva
Julia has a master’s degree in Biophysics as well as more than 10 years of experience in the pharmaceutical and medical device fields.
She’s been involved in projects from launching facilities for the production of liquid and solid dosage forms to medical device production. In addition, she’s also developed and implemented QMS from scratch, achieved GMP and ISO certifications alike, and successfully executed tech transfers.
With not only her regulatory knowledge and a strong dedication to quality principles, but also a sense for teamwork, personnel training, and leadership, she’s a competent partner for all quality related issues for both our team and customers at THE FORCE.
Raquel Correia
Raquel is a pharmacist with more than 10 years of experience in the pharmaceutical industry. Given her passion for continuous improvement, the fact that she’s driven by challenges, and her strong belief that quality is at the core of a successful company, it comes as no surprise that her specialty lies within quality assurance.
Over the course of her career, she’s not only completed almost 100 audits in GMP and GDP, from sterile manufacturing to distribution centres, but also hosted dozens of inspections by competent authorities in Europe and Eastern Asia alike.
In addition, Raquel is an expert in both the transformation, harmonisation, implementation, and monitoring of QMS and in the implementation of the falsified medicines directive and management of artworks.
Uwe Rosin
Uwe has a bachelor’s degree in Biochemistry followed by an honours degree in Pharmacology. In addition to more than 30 years of experience in the broader health care industry, he brings extensive knowledge in product development, manufacturing, technology transfer, and quality assurance to our team.
While his passions lie in technology transfer and auditing, Uwe’s excellent experience also stretches to IV solutions, devices, and allopathic as well as homeopathic preparations from inception to execution.
Through his role as Quality Manager, combined with his distinct knowledge of GMP and guidelines, he lays the foundation for fruitful and efficient cooperation with a wide variety of customers at THE FORCE.
Heike Gloede
Heike is a pharmacist with more than 18 years of experience in the pharmaceutical industry. Her background spans from working in global CROs to regulatory affairs, including leading positions in both production and quality control as well as fulfilling the function of Responsible Person.
Her expertise has already led to not only several successful inspections in Germany as well as in Switzerland, but also to gaining MIA for primary packaging units.
At THE FORCE, Heike covers the range of GCP, GMP, GDP, and quality management – and takes care of Regulatory Affairs.
Simone Groh
Simone holds a degree in chemical engineering with an additional bachelor’s degree in education, and further qualifications as PSM I and CPIM. She can look back on over 30 years of professional experience in the industry.
Ambitious with respect to high quality, familiar with norms and quality standards, and as certified QM supplier auditor, she has worked in cross-functional, multilingual teams and as a freelancer for large and medium-sized pharmaceutical and medical device companies and their suppliers.
At THE FORCE, Simone strengthens the quality team as an expert for all issues relating to quality and project management, and provides support in business development. Her focus is on projects for the introduction, implementation, further development and digitalisation of QMS using agile project management tools.
Harpreet Walia
Harpreet has more than 26 years of experience in the pharmaceutical and biotech industry. Over the course of his career, he’s not only been involved in project management and the implementation of various laboratory and industrial automation systems: he’s also become a subject matter expert in system validation, commissioning and qualification alike.
In addition, he brings hands-on experience in configuring, administering and troubleshooting state-of-the-art engineering systems and laboratory equipment – as well as multiple application software platforms.
At THE FORCE, both our team and clients benefit from the combination of his expertise with a result-oriented and customer-focused approach, and – not least – with Harpreet’s outstanding communication skills and being an excellent team player.
Dr. Juliane Meutsch
Juliane’s calling is to get things up and running, for which all her experience, from A for audit to V for vigilance, comes into play.
Alongside a PhD in biochemistry, she has more than 15 years of experience in the healthcare industry, both in medium-sized companies and in start-ups, where she incorporated the start-up spirit in the production of ATMP from human stem cells.
Over the course of her career, she has worked as head of manufacturing for cell-based medicinal products and as the person responsible for vigilance in accordance with MDR Art. 10 d. Nevertheless, her focus is just as much on medical devices as on medicinal products – and on the combination of the two.
Catarina Dias
Catarina is a pharmacist who holds an M.Sc. in Pharmaceutical Sciences. With more than 8 years of experience, she’s well-versed in GMP/GDP quality systems across pharma manufacturing and global supply environments.
Her focus includes QMS implementation and optimisation as well as global SOP creation and document lifecycle management, while her specialties also lie in project management of technology transfers, transformation projects to achieve operational excellence, and regulatory compliance within EU GMP, GDP, and ISO frameworks.
With a combination of strong problem-solving skills, a collaborative spirit, and the fact that she likes to be challenged, Catarina also supports inspection and audit preparation across multiple sites. Not least, she’s an expert in change control, CAPA, and deviation management alike – always following her principle that quality is the key to a successful company.
Brit Gründlich
Brit is a trained industrial clerk with a master's degree in Molecular Biology and Physiology. Since 2018, she has been working on both a national and international level, with professional experience in Spain in particular, in the pharmaceutical industry.
Her background ranges from supplier management and qualifications, GMP/GDP audits and contract management in the quality sector to the release of cosmetics, food supplements, and biocides.
At THE FORCE, she tackles every new challenge in quality management as well as all topics relating to GMP and GDP, such as QMS and due diligence, with her open, inquisitive, and thorough approach. Not least, her interest in cultures and languages benefits both our international team and customers alike.
Enis Unutmaz
Enis is a Chemical Engineer with an M.Sc. in Pharmaceutical Technology.
During more than 15 years of professional experience in the GxP field, he’s proven a conscientious and goal-oriented approach to his work that he now applies to projects for us and our clients at THE FORCE, as well.
With a combination of high motivation, resilience, and an outstanding spirit for teamwork, he provides a broad variety of consulting services in GxP-related topics, while also specialising in the set-up of distinguished quality management systems for our customers. Not least, he’s well-versed in performing GMP and GDP audits alike.
Nicola Giarretta
Nicola is a biologist with more than 20 years of experience in the pharmaceutical and medical device industries. He has been involved in projects related to the launch of a GMP manufacturing facility to the development and implementation of Quality Management Systems from scratch.
His expertise spans Quality Control, Quality Assurance, and Qualified Person responsibilities in both the antibiotic and combination product sectors.
With a balanced mix of his collaborative mindset, strong problem-solving skills, and his experience in designing and optimising QMS, he ensures regulatory compliance, operational efficiency, and continuous improvement for our customers – true to his conviction that a quality system developed with intelligence and pragmatism is one of the keys to building a successful and sustainable company.
Juliana Gavrilenko
Juliana has not only already more than 18 years of practical experience as a pharmacy technician: in addition to her work at the pharmacy, she attended the vocational school for cosmetics and worked as a specialist cosmetician for several years.
Through her function as quality management and occupational health and safety officer, she also brings with her a distinct understanding of quality management systems – and uses her experience in this area at THE FORCE as Quality Manager, as well.
Beatriz Reis
Beatriz is a pharmacist who also holds a master’s degree in Pharmaceutical Sciences.
She combines her degree with more than 7 years of professional experience in the field of Quality Assurance within the pharmaceutical industry, where her focus has been on the management of change control as well as on quality compliance.
As a detail-oriented person with a collaborative spirit and strong problem-solving skills, Beatriz always enjoys a good challenge and is prepared to tackle a variety of quality management related requests and issues for us at THE FORCE and our customers alike.
Lisa Mammitzsch
Lisa has a master’s degree in biology as well as a passion for economics and an interest in always expanding her horizon that she has combined in a continuing education program. Besides her studies, she can draw on more than 7 years of experience in the pharmaceutical industry, with a focus on radiopharmaceutical and blood products.
Her professional expertise in quality assurance and quality management ranges from the optimization and development of processes to covering areas such as SOPs, deviation, change control, batch release and inspections.
With an analytical, problem-solving approach, her collaborative spirit, and customer-oriented mindset, Lisa provides our clients with quality consulting and project management, the set-up and maintenance of GxP-compliant systems, and operational quality support alike.
Verena Bücker
Verena combines a bachelor’s degree in Nutritional Sciences and a master's degree in Nutritional Economics with over 8 years of professional experience in quality management, more than 5 of which spent in the pharmaceutical industry.
At THE FORCE, she continues her expertise in this field, covering areas such as SOPs, change control, and inspections. With her passion for good quality management and structured work, she has been involved in various international projects – from the creation, maintenance and improvement of the QMS in 14 European countries to site certification according to GDP in the Netherlands.
In addition, Verena is experienced in conducting both internal and external audits and in supplier qualification.
Luisa Thumm
Luisa has a degree in information management in the health sector and can draw on a wide range of practical experience in all her areas of specialisation – from quality management to business administration to project and information management.
At THE FORCE, she applies her expertise in quality management and quality assurance as Quality Manager. One of her special fields is staff qualification within the framework of training and on-boarding measures.
Her experience in regulatory affairs and product approval within Europe in particular gives Luisa an international perspective that benefits us and our clients alike.
Sabrina Sommer
Sabrina has a master’s degree in Biomedical Sciences. Her experience within the pharmaceutical and medical device industry spans more than 7 years in qualification and validation topics as well as more than 4 years in quality management.
At THE FORCE, she leverages her outstanding ability to immediately assess even difficult situations and to quickly come up with excellent solutions to provide support on all quality-related matters, with a particular focus on handling CSV issues.
Combining strong analytical skills and a calm, thoughtful, goal-oriented, and highly precise approach to her work, Sabrina is a highly reliably asset for our team and customers alike.
Kerim Kaynak
Kerim has more than 10 years of experience in the pharmaceutical industry, and over 5 years of experience in an ISO 9001-certified environment – ranging from manufacturing and quality assurance to the implementation of a comprehensive quality management system.
His areas of competence include deviation and CAPA management, equipment qualification, and batch record review, as well as document management and the delivery of trainings. In addition, he is experienced in the preparation, performance, and follow-up of internal, external and 5S audits, and has successfully supported ISO 9001 certification processes.
At THE FORCE, he combines this expertise not only with his empathetic, open, and communicative manner: with his analytical, detail-oriented streak and a pragmatic, solution-focused approach, Kerim is involved in a variety of projects within the healthcare sector. There, his focus is on maintaining GxP standards and providing support for both GxP and ISO enquiries.
Dr. Andrea Gall
Andrea is a specialised pharmacist for drug information who received her doctorate in Drug Regulatory Affairs alongside her job. She can now look back on more than 20 years of experience in the pharmaceutical industry and consultancy in this industry in total, including regulatory affairs, quality control & management, and manufacturing.
As a specialist for quality in the pharmaceutical industry, she fulfils the role of Qualified Person, Responsible Person for Narcotics and Cannabis as well as of Information Officer or Graduated Plan Officer. In addition, she performs both internal and external audits, and works as trainer for the pharmaceutical industry – in particular in the context of GDP and narcotics.
At THE FORCE, Andrea is always open to any new work challenge and enjoys presenting the latest developments in the world of regulatory and GMP to her colleagues. Her love for regulatory details is well known and has been appreciated in numerous projects.
Mario Vaccaro
Mario holds, in addition to a degree in Chemistry and Pharmacological Technology, a license as a pharmacist. With more than 10 years of professional experience in pharmacies and the pharmaceutical industry, he has specialised in the areas of GMP inspections and supplier qualification as well as internal and external audits.
He combines many years of experience in the pharmaceutical gas industry with the knowledge in the field of medical devices he gained as person responsible for regulatory compliance.
At THE FORCE, Mario realises his innate enthusiasm to always discover new areas and challenges in order to fulfil his desire for professional improvement and evelopment.
Dr. Klaudia Schönfeld
Klaudia holds a doctorate in chemistry and is a licensed pharmacist with over 20 years of experience in the pharmaceutical industry, including as qualified person according to §14 AMG (German Medicines Act) for contract manufacturers, as QP-IMP for clinical trial samples, and in process optimisation in the field of quality control/laboratory work.
Her strengths are evident both as a team player and leader: she is not only capable of directing others, but also has a pragmatic approach that allows her to take action herself, which she has demonstrated in particular as head of the quality control and assurance departments and as project manager in the galenic development of various drug forms through to approval.
For our customers at THE FORCE, she applies her expertise in all technical details in a goal-oriented manner and with an eye for the essentials – without losing sight of economic aspects.
Hugo Tavares
Hugo is a Certified Business Administrator. In addition to 10 years in the production and distribution of pharmaceuticals and experience in the field of medical technology, his specialties include export, warehouse management, and rollouts for the establishment of new companies abroad.
At THE FORCE, Hugo combines this broad wealth of experience with his ability to accurately analyse even the most difficult situations.
As a specialist in supply chain, logistics, and transportation, he approaches these issues not only with his expertise, but also with a healthy mix of diligence, rationality, and diplomatic skills. Both we and our business partners benefit from his confident approach and the open atmosphere he creates for everyone involved.
Pharmacovigilance
Rudite Schillinger
Rudite is a medical doctor and has a master’s degree in Business Administration. She has more than 20 years experience in the pharmaceutical industry.
Rudite covers pharmacovigilance quality systems, performs PV audits, monitors benefit risk balance of the medicines and maintains a pharmacovigilance system master file.
Rudite’s long-standing experience in the pharmaceutical field brings together a healthy understanding of business needs and legal requirements. She has been successful in passing EU authority inspections, performing PV audits, implementing PV systems and maintaining effective quality system for monitoring medicines.
Dr. Maren Gonzalez Schmitz
Maren dived right into the pharmaceutical industry after her studies, starting out as quality assurance and pharmacovigilance manager. Of the about 20 years since, she’s spent more than 10 in PV, covering a wide variety of topics – from implementing, monitoring, and maintaining PV systems, to adverse drug reaction reports and recalls, to the maintenance of data bases.
In addition, she’s got a doctoral degree in human biology in a clinical setting, including hands-on experience with primary cell-culture.
Making use not only of her affinity for communicating in German, English, and Spanish alike, but also of her curious nature that leads to her always being ready to learn more and to broaden her horizon, Maren has worked with partners all over the world to ensure compliance with PV obligations – which she continues to do at THE FORCE.
Christiane Pfeffer
Christiane combines a degree in pharmacy and a license to practice pharmacy with experience in both pharmacies and the manufacturing sector. In addition, she has been responsible for the implementation of a variety of tech transfer projects for large clients – from lab scale to process validation and the commercialisation of products.
With both an open mind for new things and developing herself in additional fields, most recently shown in her successful qualifications as Clinical Monitor and Graduated Plan Officer, she comes into play as a valuable allrounder in various areas of PV and Quality at THE FORCE.
In combination with her enjoyment of learning new languages and getting to know new cultures, she’s ideally equipped to work with our team and customers in an international environment.
Dr. Jennifer Eymael
Jennifer’s academic background includes a M.Sc. in Biomedical Sciences, with a focus on toxicology and human pathobiology, followed by a PhD in Biomedical Sciences. As a Pharmacovigilance Manager with more than5 years of experience, she also brings a strong focus on operational excellence in drug safety.
Her proven expertise covers safety operations for high-impact products, including the COVID-19-vaccine roll-out, as well as aligning cross-functional teams with EU and local regulatory requirements and supporting a global portfolio of over 50 products.
At THE FORCE, Jennifer continues to contribute to the safety and well-being of patients through drug safety and risk management, establishing and maintaining a PV system for our customers, and taking on all relevant PV questions and tasks – not least by utilising her passion for bridging scientific knowledge with PV strategies for drugs, vaccines, and medical devices to ensure product safety and compliance. She’s also acting as Graduated Plan Officer acc. to § 63a AMG and §19 AMWHV.
Dr. Ana Saraiva
Ana is a biochemist with a PhD in Chemical and Biological Engineering. During her 9 years in Medical Affairs, she has worked in cross-functional teams for pre-launch as well as launch activities, development and implementation of tactical plans, clinical research, and medical experts’ engagement projects.
With her global mindset, not least due to her wide range of international experiences, she pursues the diversity offered by an international working environment – and keeps on contributing to innovative solutions for us and our customers at THE FORCE.
In all her work, Ana never loses sight of her personal aspiration that the best care should be easily and timely accessible to every patient around the world.
Regulatory Affairs
Dr. Andrea Schüssele
Andrea is a certified pharmacist with a doctorate in Pharmaceutical Technology – and a passion for regulatory affairs. At THE FORCE, she is responsible for all regulatory affairs and toxicology services and has assembled a team of experts in these areas over the years.
Throughout her career, she’s gained sound knowledge in the development and approval process for medicinal products as well as experience in quality assurance and pharmacovigilance. This combination allows her to support our clients to navigate the regulatory affairs landscape effectively, with both strategic advice and hands-on implementation.
In addition, Andrea serves as a member of the Regulatory Affairs committee at Pharma Deutschland and is a lecturer in Goethe Business School’s Pharma MBA program.
Dr. Ivana Klincharska
Ivana holds a PhD in Biology. With more than 10 years of experience in the pharmaceutical industry, she supports complex regulatory strategies, life-cycle management, dossier writing, and marketing authorisation applications as well as maintenance, including direct communication with Regulatory Authorities across EU and non-EU regions.
Known for her structured, pragmatic approach and proactive problem-solving skills, she is leading a team at THE FORCE while combining efficient project allocation with both mentoring and day-to-day coordination. In addition, her work covers key account management, customer acquisition, and end-to-end project delivery, supported by solid expertise in CMC compliance, risk assessments, and due diligence activities.
Through clear decision-making, reliable execution, and not least strong stakeholder communication, Ivana brings momentum to fast-paced regulatory environments for our customers.
Dr. Sílvia Rodrigues
Sílvia holds a PhD in Biomedicine Experimental Biology. She combines over 5 years of professional experience in regulatory affairs and quality management systems under ISO 9001 and ISO 13485 with a continuous drive to expand her expertise across the pharmaceutical and healthcare sectors.
Her background provides her with in-depth regulatory and scientific know-how, including hands-on experience not only in scientific advice procedures, but also in due diligence projects and regulatory strategy development within both the EU framework and worldwide.
At THE FORCE, Sílvia’s specialties include regulatory strategy development, dossier preparation and submission, lifecycle management of marketing authorisations, and always providing professional advice to our clients. Not least, her extensive experience in scientific and regulatory medical writing complements her repertoire.
Dr. Tina Seitz
Tina holds a PhD in human biology and has more than 9 years of experience from a broad range of projects in the field of regulatory affairs. Throughout her career as Regulatory Affairs Manager, she has been responsible for the maintenance of national and international approvals, preparing and overseeing new approvals, and handling strategic and operational communications.
In her role as Information Officer, she is an experienced source of information for all questions related to product information compliance, including the regulatory review of packaging and promotional materials.
Thanks to her structured approach to work, strong self-management skills, and ongoing professional development, she is a trusted point of contact at THE FORCE for all regulatory affairs matters.
Dr. Sandra Mahr
Sandra holds a PhD in molecular biology and has specialised in medical research with a particular focus on molecular genetics, immunology, and rheumatology.
With more than 15 years of experience in the pharmaceutical area, she has not only gained in-depth knowledge in drug discovery and regulatory affairs but is also very familiar with the challenges of drug development and approval.
After her employment in the Biotech Industry, she became a consultant and now supports pharmaceutical clients in the implementation of their marketing authorisation projects – regarding possible approval strategies and project management as well as hands-on work on dossiers and applications.
Maryna Pokrovska
Maryna is a pharmacist by education with a diploma of the National Pharmaceutical University as well as a postgraduate certification in Economics and Management in Pharmacy.
From more than 15 years in the pharmaceutical industry, she brings the hands-on experience of a variety of complex, international projects, combined with the leadership and communication skills necessary to successfully interact with cross-functional teams from all around the globe.
While one of Maryna’s specialties lies in risk analysis and the development of regulatory affairs strategies for emerging markets, she’s also – not least due to her previous contributions to acquisition and in-licensing deals alike – a strong asset to our due diligence services.
Dr. Christine Berger
Christine has a background of more than 10 years in CMC and was a chemist in the production for API/drug substances for 8 years.
By combining this vast experience with a keen interest in any kind of medical question, she is an expert when it comes to assessment of changes, variation preparations, both dossier revisions and dossier writing, and other life cycle management activities. At THE FORCE, her specialties include tech transfers and providing regulatory strategy.
In addition, both our international team and customers benefit from her excellent cross-cultural competence: Not only has she been working in life cycle management of globally registered drug products as well as in a variety of markets ranging from EU to Brazil to Asian countries, she’s also used to being in touch with local offices all around the world.
Carlos Martinez
Carlos is a trained pharmacist with an MBA focused on innovation, and more than a decade of experience in the pharmaceutical industry. He has specialised in supporting companies, in particular in the Latin American market, in the drafting and execution of regulatory strategies.
Over the last years, he has further expanded his expertise in EU regulatory processes, with hands-on experience in their expansion strategies and the maintenance of regulatory approvals, while also participating as a speaker and trainer in EU-level regulatory forums. This know-how, combined with his immersion in Advanced Therapy Medicinal Products (ATMPs), has consolidated his main area of professional interest.
Adding his entrepreneurial mindset, strong regulatory strategy skills, and a genuine passion for problem-solving into the mix, Carlos brings a pragmatic and innovative approach to regulatory challenges.
Dr. Kerstin Tang
Kerstin has a PhD in Biochemistry and more than 8 years of experience in academic life sciences’ research and development. Her professional background in regulatory affairs and quality assurance for medical devices stretches across various stations within this area, from hands-on work on technical documentations, biological evaluations, and QMS to working in a German competent authority.
As a natural scientist, she brings along an analytical approach to assess RA and QA projects as well as a distinct comprehension of biological and physical processes, which she combines with a penchant for writing and compiling comprehensive documentations, and – not least – supporting customers in successfully coping with regulatory requirements.
At THE FORCE, Kerstin continues to pursue her passion for medical devices and working in an international environment as part of the Regulatory Affairs team.
Dr. med. Petar Blažević
Petar is a Medical Doctor whose professional career has focused on regulatory affairs, medical writing, and healthcare regulation. He has held leadership roles within scientific, clinical, and risk management functions in the medical device industry, supporting product development and conformity assessment as well as national and global regulatory submissions – always while prioritising patient safety.
During his time as a clinical expert within a national regulatory authority, he gained comprehensive knowledge in the evaluation and regulation of medicinal products, medical devices, and clinical trials. Also contributing to the development and implementation of not only regulatory frameworks but also legislation and guidance documents, he further expanded his skillset.
By combining his medical training with extensive regulatory expertise, Petar provides strategic guidance in complex regulatory challenges and develops science-based strategies throughout the product lifecycle for our clients at THE FORCE.
Dr. Manuela Mattera
Manuela is a biochemist with a PhD in Molecular and Cell Biology and a scientific background in infectious diseases, bacteriology, and virology. She can look back on more than 5 years of experience in clinical research, in particular in the project management of phase I and II clinical drug trials, which she acquired in various international research laboratories both in Germany and abroad.
At THE FORCE, Manuela continues to pursue this passion for working in an international environment and communicating in foreign languages as part of the Regulatory Affairs team, with an initial focus on renewal procedures.
As a natural scientist, she brings along an analytical approach to classify data, a distinct comprehension of physical processes, and the creative resourcefulness needed to take on a variety of projects.
Alina Licova
Alina holds a master's degree in Pharmaceutical Sciences and brings over 9 years of pharmaceutical industry experience to her role.
Her professional journey includes a wide spectrum of European and international projects, spanning product registration, procedure management, life-cycle activities, maintenance of Marketing Authorisations, and quality control.
Her expertise has not only resulted in numerous successful variation submissions as well as in securing approvals for cannabis-based products across various countries: Combined with her distinct problem-solving skills, it forms the cornerstone of her collaboration with a broad range of clients at THE FORCE.
Isidora Bojkov
In addition to a M.Sc. in Pharmaceutical Sciences, Isidora can rely on her strong background in formulation and process development, technology transfers, and CMC documentation, making her a versatile regulatory affairs professional with deep expertise in life-cycle management of medicinal products and regulatory strategy.
She combines this scientific foundation with a growing expertise in dossier writing, regulatory submissions, and communication with authorities. Not least, her hands-on experience in R&D, from designing laboratory trials to scaling manufacturing processes, gives her a scientific and detail-oriented approach to even the most complex regulatory issues.
Passionate about her work, curious, and always eager to acquire new skills, Isidora is ready for a new challenge at any time – an attitude that benefits our team at THE FORCE and our clients alike.
Jules Berßem
Jules has a master's degree in chemistry. After entering the pharmaceutical industry at an analytical service provider in the field of quality control, with focus on method development and validation, they found their way to Regulatory Affairs, which is continued at THE FORCE.
With experience spanning the full dossier lifecycle, Jules supports complex regulatory activities ranging from drafting and updating Module 1 documents, including product and technical information, to compiling Module 3 content and performing gap analyses for new market submissions. Their expertise also includes lifecycle management, risk assessments, dossier writing, and technology transfers.
Thanks to a particular strength in the preparation and submission of marketing authorisations across the DACH Region (Germany, Austria, and Switzerland), our clients are supported in keeping products compliant, up to date, and moving forward.
Dr. Elise Endres
With her background as a certified pharmacist and practical expertise in pharmaceutical insulin production, Elise brings a powerful mix of scientific depth and hands-on industry knowledge to the field of Regulatory Affairs. A key focus of her work is global regulatory compliance and coordination of product labelling and artworks.
At THE FORCE, she leverages her passion for medicines and international regulatory knowledge to support clients throughout the entire product lifecycle, from regulatory submissions and procedure management to post-marketing surveillance.
By combining her meticulous attention to detail, distinct problem-solving skills, and a team-oriented approach, Elise is an invaluable asset to both our customers and our team.
Stephanie Köster
Stephanie combines a doctor’s degree in Pharmacy with more than 15years of professional experience in a broad range of cross-disciplinary projects, bringing holistic approaches in the Regulatory Affairs field.
A focus on international labelling harmonisation, packaging development and supply, and project management optimisation allows her to bring innovation and efficiency into labelling, artworks, and packaging projects as well as processes at THE FORCE. Here, she also applies her expertise and creative problem-solving skills to support our clients in their business strategy.
Not least, her proficiency in French, German, English, and Spanish, as well as her formal education in communication and leadership, make her a sharp intercultural communicator who excels at building and maintaining effective working relationships to close gaps in a global team setting.
Beatriz Moreira
Beatriz is a pharmacist by training with professional experience in a community pharmacy, including in the position of Assistant Pharmacy Manager. During this time, she not only supported daily pharmacy operations: her responsibilities involved the assurance of safe and accurate dispensing, patient counselling, and compliance with the national authority regulations.
Channelling her keen interest in regulatory affairs and pharmaceutical compliance into completing a specialisation in Regulatory Affairs and Technical Direction, she has further strengthened her knowledge in regulatory strategy, technical documentation, and product lifecycle management.
At THE FORCE, Beatriz provides support to our customers in various areas of regulatory affairs, from regulatory submissions to identifying potential compliance risks.
Lea Englhard
Lea is a licensed pharmacist. Her professional experience ranges from working at a generic drug manufacturer with a focus on labelling and artwork to managing the lifecycle of Europe-wide marketing authorisations.
Alongside her experience in an international environment, particularly in the area of Europe-wide variation applications, Lea shines with her drive to always pick up new knowledge and skills.
At THE FORCE, she is therefore responsible for a wide range of regulatory tasks for our clients, which she handles with her expertise, attention to detail, and – not least – a knack for creative solutions.
Inesa Mikulane
Inesa is an accomplished Regulatory Affairs and Quality leader with over 15 years of experience across the pharmaceutical industry and national competent authority environments. Providing strategic oversight of EU/EMEA regulatory compliance, lifecycle management, and variations are as much part of her expertise as labelling & artwork governance, quality systems, and CMC-related regulatory documentation.
With a career background ranging from leadership roles within the national regulatory authority to representing Latvia as Reference Member State, Inesa brings a strong regulatory judgment mindset to industry roles.
A proven track record of not only health authority engagement, but also implementation of frameworks and ensuring both business continuity and compliance at local, regional, and EMA levels makes her a trusted advisor to cross-functional and senior stakeholders – and to our clients at THE FORCE.
Nicole Peter
Nicole is a nutritional and domestic scientist always eager to expand her skills – and a Regulatory Affairs Manager with 10 years of professional experience. With a focus on borderline products and monopreparations, she’s supported both national and international registrations, from EU and Non-EU to Latin America and Asia alike.
Over the course of her career, she’s successfully operated as interface to different parties, connecting colleagues and customers as well as surveyors, authorities, and associations. Not least, search for customer requests is as much part of her expertise as portfolio assessment, including the identification of non-profitable products.
At THE FORCE, Nicole is managing the RA lifecycle as well as other regulatory activities in her pragmatic and precise way, while also conducting regulatory research and both reviewing and ensuring compliance of product labelling and packaging.
Toxicology
Dr. Heidi Becker
Heidi is a biologist whose academic background includes a degree in toxicology as well as a PhD in the field of cell toxicology. In addition, her skills and expertise have been certified by her holding the qualification of European Registered Toxicologist (ERT).
Over her 20 years of professional experience, she’s worked for both the Federal Environment Agency, with a focus on the assessment of indoor pollutants and on nanomaterials, and as a REACH officer in the chemical industry.
With her vast experience in consulting and advisory services – and a special knack for safety data sheets – Heidi also ensures that both we and our customers at THE FORCE are best informed. In this she covers areas ranging from the Non-Clinical Overview (Module 2.4) as part of the CTD, to deriving important limit values, up to the toxicological assessment of ingredients or impurities in drugs and medical devices.
Célia Martins
Célia has a degree in Eng. Biotechnology and started her career after graduation as a researcher in the field of genetic toxicology. Upon completing her PhD in Life Sciences with a specialty in human genetics and toxicology, she gained hands-on experience in GLP laboratory environments – including study design, method implementation, and quality system alignment – by fulfilling the role of both coordinator and GLP Study Director within a phytopharmaceutical company laboratory.
Her expertise extends to the preparation of Environmental Risk Assessments (ERA), Permitted Daily Exposure (PDE) derivations, toxicological risk assessment, qualification of impurities, and non-clinical overviews.
At THE FORCE, Célia follows her passion for toxicology and working with a multidisciplinary team in an international environment. In her work, it’s central for her to deliver expertise for a better life, with less exposure risk, and to ensure scientific robustness and compliance with current regulatory expectations.
Henry Nwokedi
Henry combines not only a bachelor’s degree in Pharmaceutical Sciences with a master’s degree in Toxicology, but also has a background of several years of experience in Pharmaceutical Care.
At the FORCE, he continues to pursue his area of passion by joining the team in solving toxicology-related problems, while also following his ambition to constantly expand his knowledge and skills to other topics in the pharmaceutical industry.
Procurement & Supply Chain
Valentin Degenhardt
Valentin is a results-driven Procurement and Supply Chain leader with over 20 years of cross-industry experience. At THE FORCE, he supports clients by turning complex transformation agendas into rapid, scalable execution – always with clarity, energy, and a sharp focus on value. This way, he enables organisations to unlock the full potential of Procurement and Supply Chain as a pacemaker for growth and value creation.
Customer-centric and execution-focused, he combines strategic perspective with hands-on implementation. He leads end-to-end initiatives ranging from operating model design and Procurement and Supply Chain transformation to supplier and category management and cost optimisation.
Guided by a strong ONE TEAM mindset, Valentin consistently translates strategy into measurable impact, delivering results as well as sustainable momentum.
Agustin Obarrio
Agustin is a senior operations and supply chain executive with more than 15 years of experience across pharmaceutical and FMCG industries in Europe and the Americas. He supports organisations in transforming and scaling operations in highly regulated environments, consistently driving operational excellence and performance.
By combining strategic perspective with hands-on execution, he leads cross-functional teams and delivers end-to-end supply chain improvement, including ERP implementations and lean transformations as well as logistics network setup.
With a pragmatic, results-driven approach, Agustin focuses on operational transformation, performance governance, and cost transparency to unlock efficiency and sustainable growth.
Matias Carrillo
Always focused on customer satisfaction as if any company were his own, Matias provides added value through his in-depth analysis, strategic planning, and implementation of practical and creative solutions.
An academic background including a master's degree in International Business, Trade, and Law has allowed him to develop his professional skills for more than 9 years in international transport & logistics sectors.
With successful experience in cost optimization projects and the implementation of technological solutions to solve complex situations alike, Matias continues at THE FORCE to support our clients in meeting the major challenges of procurement and supply chain.
Priyanka Shetye
Priyanka’s academic background includes a bachelor’s degree in Chemistry, a master’s degree in Supply Chain & Logistics Management, a diploma in Material Management, and the Lean Six Sigma Green Belt certification. Her collective professional experience is just as diverse and covers 15 years, with specialties spanning from strategic sourcing and external manufacturing to global supplier management.
With a proven track record in cost reduction, value creation, and complex procurement negotiations as well as a deep understanding of both pharmaceutical supply chains and regulated environments, she also delivers supply chain transformation, process improvement, and execution of global sourcing strategies.
Known for not only her ownership mindset but also her analytical thinking and execution-driven approach, Priyanka is able to translate strategy into measurable business results – from advisory to implementation.
Daniel Júlio
Daniel has a degree in Logistics and Industrial Management. His professional experience includes process improvement for supply chain and customer service as well as demand planning, the latter amounting to a multi-disciplinary role that required contact with the areas of supply chain, process improvement, and data analysis alike.
In each of his positions, he has demonstrated his strong organisational skills and a distinct problem-solving approach, while also bringing in a healthy dose of creativity, in particular regarding process modification and creation.
At THE FORCE, he combines this expertise to provide the best solutions in procurement and supply chain to our customers.
Transformation & Strategy
Patrick König
Patrick combines a degree in Business Administration with nearly 20 years of extensive experience in the pharmaceutical industry, in particular in the areas of Speciality Pharma and CDMO.
He has proven his leadership qualities over a period of more than 5 years in managerial roles and established them within the framework of 2 years in executive positions.
At THE FORCE, Patrick leads our transformation and strategy team with not only his expertise ranging from sales and marketing to M&A to the reframing of organisations, but also with a strong hands-on mentality, his open-mindedness, and a special dash of creativity that all allow him to always find the best solutions for our clients.
Project & Process Management
Dr. Markus Lutz
Markus holds a diploma in Business Administration and a doctorate in Innovation Management. He has about 20 years of professional experience in industry and consulting, more than 5 years thereof in executive positions. With his distinct ability to structure and prioritise, he assists our clients in making the right decisions at the right time.
Markus has long-term experience in project management as well as in lean management. He has been very successful both as manager and consultant for production, logistics, and R&D within various industries, such as – besides the pharmaceutical industry – medical devices, automotive and machinery.
At THE FORCE, Markus covers project, multi-project, and program management as well as process development and optimisation.
Karla Giacomelli Ribas
Karla is a pharmacist with a master’s degree in Pharmaceutical Sciences. She brings extensive experience in drug product development, analytical research and development, stability studies, and project management within highly regulated pharmaceutical environments.
Throughout her career, she has developed sound expertise in the application of good practice (GxP) guidelines, supporting activities ranging from analytical method development and validation to technology transfers, regulatory documentation, and GMP compliance projects.
With more than 10 years of professional experience, Karla combines her scientific background with strong analytical and leadership skills to successfully manage complex projects and cross-functional teams at THE FORCE.
Specialty Services
Laura Leupolt-Krahn
Laura has spent more than 20 years in the area of OTC, food supplements, and RX. Her specialties lie in sales and business development, contract manufacturing across a wide variety of different dosage forms, and the in- and out-licensing of technologies and products alike.
Also well-versed in commercial operations and leading teams, she’s got hands-on experience in setting up an office, including everything from building up a team, developing a customer base, and establishing customer relationships.
Combining this expertise with her prior roles and contacts, she’s best prepared to interact with international teams, partners, and customers in the field of business development at THE FORCE, as well.
Alexander Oblezov
Alexander is a chemist with more than 20 years of professional experience in the pharmaceutical industry, including stations in general management and as a plant manager. His expertise is in product development, tech transfer and manufacturing.
As an experienced project manager in various fields of medical devices and the pharmaceutical industry, he uses his diverse background – ranging from construction projects to drug solid form optimization – to take care to take care of managing manifold projects at THE FORCE, as well.
Dillon Abraham
Dillon combines a degree in Biology and Biotechnology with a Bachelor of Commerce and 10 years of professional experience in the area of quality and supply chain.
At THE FORCE, he is currently working on business development by identifying new clients as well as opportunities, and provides details on capital plans, budgets, and services for short- and long-range customers alike.
While Dillon’s expertise includes chemical and microbiological laboratory analysis and compliance, he also specialises in change management, risk management, both validation and qualification, and project management. Not least, he’s well-versed in leading teams for on-time delivery for us and our clients.
Deniz Yildiz
Deniz holds a bachelor’s degree in computer engineering. She’s not only completed an internship as a front-end developer, but also has already been gathering practical experience while pursuing her degree by working in the field of web development for various start-ups.
Within the scope of her graduation project, she’s used artificial intelligence as well as natural language processing (NLP) in the development of a daily life recommendation application. Beyond her general interest in software development, she has a strong passion for game development, which has led her to being selected for the Google Game and Application Academy, as well.
At THE FORCE, Deniz brings her skills together and continues her career as a Full Stack Developer.
Yunus Kaydan
Yunus is a Computer Engineering graduate with professional experience in AI engineering and software engineering alike. He has worked in e-commerce, AI startups, and as a freelance software engineer for various companies before joining us as part of our software development team.
In addition to his contribution to TÜBİTAK-qualified projects and being a finalist and awardee at TEKNOFEST with projects in the field of Automated Guided Vehicles, he already extended his expertise during his time at university: there, he was engaged in award-winning entrepreneurship projects.
At THE FORCE, Yunus continues to apply his software engineering expertise, in particular in his role as Backend Developer.
Beatriz de Lima
Beatriz has a master’s degree in Graphic Design and Editorial Projects, and has been working as a graphic designer within the healthcare industry for the last couple of years.
While her core competence lies in packaging and overall offline media, such as cartons, informative flyers, or outdoor advertising, she’s also well-versed in and passionate about other forms of digital art and areas of application, from social media to illustration.
With a focus on improving graphic design communication and the goal to make a positive impact on people’s lives through the pharmaceutical field, she provides both us at THE FORCE and our clients with solutions to a wide variety of artworks and other design needs.
Renata Ferreira
Renata has a bachelor’s degree in Graphic Design and more than 10 years of experience in creating artworks and marketing campaigns for the pharmaceutical industry. Throughout her career, she’s not only built up a wide-ranging background, from conceptual design to final execution: she has also taken on the lead in cross-functional design projects, collaborating closely with marketing, product, and regulatory.
Two additional specialisations in UX Design and a completed training in Branding and Service Design allow her to approach projects from a strategic and user-centred perspective, as well.
As part of our design and art team at THE FORCE, Renata is involved in supporting our corporate branding strategy and developing artworks for our clients – always ensuring consistency across all design materials and making sure both regulatory standards and creative objectives are met.
Company Support
Douaa Hussien
Douaa is a business economist with a focus on Finance & Controlling and Business Administration. Motivation, sense of responsibility, reliability and flexibility characterise her strengths.
With her organizational talent, she not only generally supports the team in analysing, planning and controlling financial tasks in the company, but also takes on her own projects in this area.
It is important to Douaa to always have a clear plan that allows her to achieve the goal and to identify deviations early on.
Tanja Dreher
Tanja holds a master’s degree in International Business & Economics with a focus on marketing and global business ethics and has over 10 years of professional experience in the field of marketing.
Her core competence lies in the area of online marketing – not least because of her curiosity about new technologies and her openness for the use of new systems. With Tanja, distinctive analytical skills meet a creative streak, which is evident in her ideas as well as in their practical implementation.
With her experience in the development, control and analysis of holistic marketing concepts, she is responsible for campaign management and the implementation of marketing activities on all channels at THE FORCE.
Regina Werdehausen
Regina is a nutritionist with more than 6 years of professional experience in scientific field work, project management, and marketing for Food for Special Purposes (FSMP).
She unites an analytical and structured approach to her work with an openness towards new challenges—and, not least, with sensitivity in dealing with people. This is not only evident in her close collaboration with other teams: it also enables her to communicate the added value of products to customers, always tailored to their individual needs.
Combined with a knack for creative solutions and the fact that she always keeps an eye on the market, Regina ensures the optimal positioning and marketing of products at THE FORCE, as well.
Nikolai Wiedemann
Nikolai has a university degree in Information Management with over 10 years of experience in IT systems and system landscapes. As our technical mastermind, he takes care of everything related to technology, with his core competence in IT project management: He combines strategic and conceptual elements with the necessary technical know-how for a target-oriented implementation.
Thanks to his penchant for IT security and a passion for everything that consists of zeros and ones, he keeps himself and the IT landscape at THE FORCE constantly up to date, even with the fast-moving developments in the IT sector, and continues to develop both.
Moreover, he ensures that all employees have quick and uncomplicated access to all the resources they need to develop their business areas.
Andre Braga
In addition to successful studies in Computer and Telecommunications, Andre has built up and expanded his IT support skills in stock market as well as hospitality companies throughout his career.
Infrastructure management and security architecture development are equally part of his daily routine as getting up to date with current trends and exploring the world of Tech, as he always seeks to draw on the latest expertise and test new solutions in his work.
At THE FORCE, Andre also takes on IT support, enjoying the opportunity to assist colleagues and customers alike, the sense of accomplishment in solving even the trickiest issues – and the fact that the fast-paced IT environment makes every day a new challenge.
Kadir Sert
Kadir holds a bachelor’s degree in Information Technology with a focus on network security, which is complemented by a master’s degree in Management and Organisation.
Over the course of his career and various key roles, he’s significantly contributed to advancing technology in healthcare services: He has successfully lead teams in implementing innovative solutions, enhancing cyber security measures, and optimising IT operations in alignment with organisational goals.
Driven by his passion to continuously develop the IT landscape, Kadir always brings his expertise, leadership skills, and not least his priority to foster collaborative and positive work environments to the challenge at hand – and thus succeeds in driving impactful change.
Verena Winter
In addition to a bachelor’s degree in business administration, Verena has several years of professional experience from various projects in HR and assistance. Combined with her interest in languages, traveling, and getting to know international cultures, she is well-equipped to deal with the diverse pool of candidates and employees at THE FORCE.
As Head of HR, she is not only responsible for advancing HR management processes to meet organisational requirements arising from growth and internationalisation of the company: she’s also leading the HR team to ensure the quality of HR services in order to enable all employees to reach their best potential – true to our motto “people are our strength”.
Verena acts as a point of contact for employees, managers, and management alike – and is always up to date with the latest trends and developments.
Diana Borges
Diana has a master’s degree in Psychology. Alongside of this, she has more than 6 years of professional experience as an administrative assistant in the footwear component industry as well as a background of working in a dentist clinic.
As not only a great team player but also as someone who likes to support other people in their development and to help them grow, both on a professional and personal level, she is a great asset for our team at THE FORCE.
In addition, Diana takes care of the wide range of day-to-day HR responsibilities.
Karin Johnson
Karin pairs a Bachelor of Business Administration with a strong background in banking and customer service as well as over 15 years of experience in managing large teams.
In combination with a well-organised, inclusive way of work – and not least with a good dose of determination – she uses her skills to guarantee a smooth and efficient administration of our Berlin office.
Always eager to dive into the latest software developments, learn to use new tools, and try out current trends, the most recent addition to her expertise is a diploma in Digital Marketing and Social Media which she puts into action at THE FORCE in her role as Social Media Manager.
