The key to successful authorization of clinical trials
Profil has the expertise to guide our partners to success with regulatory submissions for clinical trials. We have dealt with authorities such as the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte; BfArM) and the German Ethics Committees (ECs) for 15 years and know how to minimize or even completely avoid delays in the approval process.
Our clinical regulatory affairs team members hold Master’s degrees in drug regulatory affairs and have many years of experience in medicinal product and medical device submissions. They thoroughly review each submission package and help address critical issues prior to submission.
Profil has submitted more than 350 trials to the BfArM and/or German ECs since the implementation of Clinical Trials Directive 2001/20/EC. This number includes multiple successful submissions of medical device trials under 2010’s European Directive 93/42/EEC.
Facts and Figures
Experience in Clinical Trial Application filing, including assistance in preparation of the Investigational Medicinal Product Dossier (IMPD)
Experience with submissions of medical device trials in accordance with the Medical Device Law in Germany (MPG)
Submission of all necessary documents to ECs and competent authorities
Assistance in answering deficiency letters from ECs and competent authorities
Tracking of all relevant timelines using specific databases