Interacting with the responsible medicines authority early on in the development process may be helpful for those who need more information about the quality, safety, and efficacy requirements for medicinal products with regard to the authorisation of clinical trials and national marketing authorisation. The Paul-Ehrlich-Institut (PEI) therefore provides early scientific advice and regulatory guidance support medicinal product development from initial discovery to conducting clinical trials to authorisation and beyond.
Advice at the Paul-Ehrlich-Institut should support your pharmaceutical development on an individual basis and as early as possible. For this reason, we provide tailor-made advice specific to the developmental phase of the respective medicinal product - ranging from the development of an active substance to its mechanism of action in the non-clinical phase to the first clinical application and subsequent marketing authorisation. . The conversations focus on areas such as specific scientific aspects with regard to regulatory requirements.
Advice at various stages in medicinal product development.
Source: Paul-Ehrlich-Institut
Innovation Office
Phone: +49 6103 77 2772
Email: innovation@pei.de
Application form on PharmNet.Bund
Updated: 01.07.2025
