Advice

National Advice at the Paul-Ehrlich-Institut

Based on the requirements for medicinal products with regard to quality, efficacy, safety, and environmental risk assessment, early interaction with regulatory bodies fosters the translation of research findings into products and product development. Therefore, the Paul-Ehrlich-Institut (PEI) provides early scientific advice and regulatory guidance to promote efficient translation of basic research findings into new treatment approaches.

Since August 2018 the Innovation Office at the Paul-Ehrlich-Institut has organised and coordinated the national advice meetings for all products within the Institute's scope.

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 scientific and procedural advice meetings which are specific to the developmental phase of the respective product - ranging from drug discovery to the non-clinical stage, and finally first clinical use and subsequent licensing. Scientific aspects related to quality, non-clinic and clinic are discussed with regard to the corresponding regulatory framework.

Scientific and procedural advice at different stages of product development

1. Therapy concept
2. Manufacturing process
3. Non-clinical development
4. Clinical development
5. National authorisation
6. With a view to a centralised marketing authorisation

Contact

Innovation Office
Phone: +49 6103 77 2772
Email: innovation@pei.de

You will find our application form as well as further information under the heading Consultation formats.