Regulatory research and risk assessment in drug development

Evaluating and assessing the risks and benefits of innovative medicinal products

Fraunhofer ITEM has combined its expertise in drug research and development with its experience in registration and risk assessment of chemicals. With these forces joined, the institute is uniquely positioned to support clients in regulatory affairs in the drug development process. Our scientists explore, develop, and validate new approaches to manufacture, characterize, and test innovative medicinal products, ensure regulatory input on these approaches, and implement them in product development in cooperation with the client.

Our expertise allows experimental studies for risk assessment and registration of substances to be goal-oriented and focused on what is really needed. We support our clients in regulatory affairs and risk assessment.

Our services and expertise

Preparation of a regulatory strategy

Project planning focusing on regulatory compliance, integration and cross-linking of different R&D disciplines, regulatory troubleshooting and addressing of regulators‘ concerns

Interaction with regulatory authorities

Scientific and regulatory advice meetings with authorities (e.g. national competent authorities, EMA, FDA), application for authorization of clinical trials (national authorities, ethics committee), ATMP classification and certification, application for orphan drug designation, access to EMA’s , “PRIoritiy MEdicines” (PRIME) scheme and FDA’s “breakthrough therapies”

Environmental risk assessment (ERA) for marketing authorisation of veterinary and human medicinal products

Pharmaceuticals that are to be marketed in Europe must always seek marketing authorisation by the competent authorities. The environmental risk assessment (ERA) is an important part marketing authorisation application (MAA) dossier.

For our clients in the pharmaceutical industry, we evaluate the necessary data, draw up the ERA for the application in line with the regulatory requirements and provide support with compiling all the required documentation, developing suitable testing strategies and engaging in discussions with the competent authorities. 

Preparation of the required documentation

Study reports in formats acceptable to the regulatory authorities, support in dossier preparation (e.g. IMPD, CTD), core documents according to ICH E6 (e.g. IB, CTP)

Regulatory research

Development of new tools, standards, and approaches for assessment of regulated products, critical path research along the development process

Your benefit

Regulatory research and risk assessment in drug development
© Fraunhofer ITEM, Ralf Mohr

We act as interface between clients and regulatory authorities, actively participate in panels preparing legislation, and collaborate with national and international scientific organizations.

  • Project-specific regulatory team is recruited within Fraunhofer ITEM:
  • Scientific experts in drug development from in-house development platforms (process development and manufacturing of biopharmaceutical investigational medicinal products, non-clinical testing, and clinical trials)
  • Regulatory experts
  • Risk managers
  • Involvement of expertise tailor-made to the specific requirements of drug development

How we work

We provide two types of services: firstly, we support Fraunhofer ITEM’s laboratory-based and clinical contract research in the fields of manufacturing, non-clinical and clinical development; secondly, we perform services in regulatory affairs and related consulting as stand-alone services.

Either way, our services are centrally coordinated based on a project management approach, meaning that each client has a single point of contact to address daily business. The project-specific regulatory team, consisting of scientific and regulatory experts as well as risk managers, is recruited within Fraunhofer ITEM to ensure availability of expertise tailor-made to the task's specific requirements.


Sebastian Konzok

Contact Press / Media

Dr. Sebastian Konzok

Business Development Preclinical Pharmacology, Chemical Safety and Assesment and Toxicology

Phone +49 172 410 7965