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Advice for License Applicants and Pharmaceutical Industry

Innovation Office: Advice on the development of ATMPs
DKTK: Scientific and regulatory advices for translational DKTK-projects
DZIF-OSRA Office for Scientific and Regulatory Advice at DZIF
National scientific advice
Scientific Advice by EMA / Protocol Assistance by EMA

Considering the requirements for medicinal products with regard to quality, efficacy, safety, and environmental risk assessment, early interaction between the pharmaceutical and biotechnology industry, physicians, veterinarians and basic researchers with regulatory bodies has been shown to foster translation of research findings into products and product development. Therefore the Paul-Ehrlich-Institut provides early scientific advice (starting at the stage of drug discovery) and regulatory guidance to promote efficient translation of basic research findings into new treatment approaches and applications for the diagnosis, prevention and treatment diseases.

The Innovation Office of the Paul-Ehrlich-Institut provides informal advice on the development of advanced therapy medicinal products (ATMP) to industry and academia, often especially welcome by academic institutions as well as small and medium-sized enterprises.

For the German Consortium for Translational Cancer Research DKTK ("Deutsches Konsortium für Translationale Krebsforschung") the Paul-Ehrlich-Institut provides regulatory guidance on new treatment approaches and applications for the diagnosis, prevention and treatment of oncological and hematological malignancies.

Within the framework of the German Center for Infectious Diseases DZIF ("Deutsches Zentrum für Infektionsforschung") the Office for Scientific and Regulatory Advice DZIF-OSRA supports the development of innovative vaccines against infectious disease and of anti-infectives. DZIF-OSRA is part of a translational infrastructure called Product Development Unit (PDU), which consists of the DZIF Translational Project Management Office (DZIF-TPMO) at the HZI in Braunschweig and the DZIF-OSRA at the Paul-Ehrlich-Institut. DZIF-TPMO will advise on commercial aspects and thereby supports the product development process.

The Paul-Ehrlich-Institut provides scientific and procedural advice for future applicants, sponsors of clinical trials, and marketing authorisation holders in all phases of development of vaccines and biomedicines.

In addition to this form of advice, the Paul-Ehrlich-Institut is also actively involved in and provides a link to scientific advice / protocol assistance provided by the European Medicines Agency EMA.

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