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.