FAQ
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Do you have a great product concept but are unsure how to develop it?
Our regulatory expertise can lay the foundation for your product development:
- Develop your Target Product Profile
- Perform a Regulatory Gap Analysis
- Clarify your Non-Clinical Product Development Pathway
- Assist with ATMP Classification
- Define your Regulatory Strategy
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Do you need expert guidance on quality and GMP compliance?
We offer tailored strategies to help you navigate and fulfil regulatory quality requirements
- Perform a Quality / GMP Gap Analysis
- Build your non-GMP / GMP Comparison Strategy
- Prepare your Quality Strategy to align with IMPD requirements
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Are you planning for your first Scientific Advice Meeting?
Our team can assist you every step of the way, providing strategic advice and practical support to ensure a successful and productive outcome:
- Assist with Early Regulatory Interactions (e.g. with PEI, BfArM, EMA)
- Develop your Briefing Book
- Advise and participate in Scientific Advice Meetings
- Streamline your Regulatory Strategy to align with the Regulatory Authority
What is the RSU?
Your Partner in Product Development
The Regulatory Support Unit (RSU) was established in June 2024 as part of the National Strategy for Gene and Cell Therapy. Funded by the German government, we provide free, independent and confidential regulatory advice to publicly funded research groups throughout Germany. Our focus is on early-stage, non-clinical product development, helping you to “think like a regulator” by keeping the end product in mind. This reverse planning approach reduces risks and costs, avoids repetition or unnecessary work and so accelerates your journey to the clinic.
Contact Us: reg-support@bih-charite.de
Meet the RSU Team
The RSU team, led by the highly experienced regulator Dr Christoph Conrad (formerly the Paul-Ehrlich Institute (PEI), the World Health Organization (WHO), the BMBF, and the German Chancellery), brings a wealth of regulatory and scientific expertise from a variety of fields.
Dr Conrad's deep understanding of both the regulatory and funding landscapes is complemented by our team's extensive academic and industry experience. Our research expertise spans protein biochemistry, neuroscience, virology (incl. cell-based vaccines), and cancer immunotherapy, (incl. CAR T cells, CAR NK cells). Meanwhile, we have hands-on experience in start-ups and GMP manufacturers as well as biotech and big pharma, where we have contributed to the development of a wide range of medicinal products including biologicals and ATMPs.
With decades of collective experience, we excel in guiding products from the discovery and preclinical stages towards the clinic. To achieve this, we have effectively navigated the regulatory landscape and have a strong track record in advancing product quality and manufacturing processes towards Good Manufacturing Practice (GMP) compliance as well as in engaging with key regulatory bodies. This includes gaining valuable guidance through Scientific Advice Meetings (PEI, BfArM), securing Orphan Drug Designations (EMA, FDA), and proficiently coordinating Clinical Trial Applications (CTAs), all of which are integral to the successful progression of product development.
This diverse background ensures that you receive comprehensive support tailored to the unique characteristics of your product, addressing both its regulatory and quality requirements, to help you navigate the multifaceted path from discovery towards the clinic.
Contact Us: reg-support@bih-charite.de
Team Regulatory Support Unit (Kopie 2)
Dr. Sofia Banchenko
Scientific Project Manager Regulatory Affairs
Dr. Michael Moles
Scientist and Regulatory Affairs Specialist for Biologicals
Dr. Barbara Volz
Scientist and Regulatory Affairs Specialist for Biologicals
Dr. Rachael Ward
Scientist and Regulatory Affairs Specialist for Biologicals
NEWS
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Regulation as a Compass – RSU in Frankfurt & Dresden
On May 18–19 in Frankfurt am Main, the RSU attended the Joint ForTra-BIH Workshop on Gene and Cell Therapy, “Where do we stand and where do we (want to) go?”. A wide range of topics in gene and cell therapy translation, regulation, and clinical development were presented. Speakers from academia, industry, and regulatory units discussed challenges and opportunities in advancing innovative therapies from research to application. Dr. Christoph Conrad, Head of RSU, highlighted how regulatory strategy can act as a guiding framework for academic translation. On June 2–3, 2026, Dr. Julia Hütter, Deputy Head of RSU, represented RSU at the SAXOCELL Conference in Dresden, titled “From Lab to Life: Advancing Cell and Gene Therapies Together,” where she presented a shortened version of the same topic, contributing to discussions on bridging innovation and clinical implementation.
Download here, Pdf (2 MB) -
Key stakeholders promote the implementation of regulatory sandboxes and platform technologies as enabling factors for innovation and improved regulatory efficiency
The revised EU pharmaceutical legislation is expected to enter into force in 2027 and represents the most significant reform of the EU pharmaceutical framework in the last 20 years. Its main objectives are to enhance regulatory efficiency and promote innovation. Platform technology and the regulatory sandbox are considered two key enablers of these goals. Although both concepts were first introduced more than two decades ago, they have now been formally included in the proposal for the reform of the EU pharmaceutical legislation. Legislative negotiations are still ongoing, but there is growing consensus that both platform technology and the regulatory sandbox can serve as important innovation-enabling tools.
Download here, Pdf (2 MB)
