Regulatory research and risk assessment in drug development

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.

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

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.