Regulatory Support Unit

Accelerate Your Product Development with the Regulatory Support Unit (RSU) | At the RSU, we specialize in guiding you through the complex regulatory environment that governs the development of Advanced Therapy Medicinal Products (ATMPs) and biologicals.

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

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

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

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.

The RSU can help define your end product and guide you through the key, early stages of development.

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.