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 higher federal authorities, mainly the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte; BfArM) and the German Ethics Committees (ECs) for over 20 years and know how to minimize or even completely avoid delays in the approval process.
Members of our clinical regulatory affairs team 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 500 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.
We have submitted the first trials based on Regulation (EU) No 536/2014 (Clinical Trial Regulation – CTR) for medicinal products, because as of 31 January 2023, for all new initial clinical trial applications in the European Union (EU)/European Economic Area (EEA) the use of the Clinical Trials Information System – CTIS became mandatory.
Furthermore, we are familiar with submitting trials under Regulation (EU) 2017/745 (Medical Device Regulation = MDR) for medical devices.
Facts and Figures
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Experience in Clinical Trial Application filing, including assistance in preparation of the Investigational Medicinal Product Dossier (IMPD)
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Experience with submissions of medical device trials in accordance with national and European medical device legislation
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Submission of all necessary documents to ECs and competent authorities
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Assistance in answering deficiency letters from ECs and competent authorities
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Tracking of all relevant timelines using specific databases
Hand in hand with our regulatory experts, our clinical development consulting team designs and prepares regulatory submission. Learn more about the clinical development consulting activities.
