In order to avoid any delays in gaining regulatory approval, it is essential to be very familiar with the requirements of a clinical trial application (CTA) in Europe, including those for the pharmaceutical quality described in the investigational medicinal product dossier (IMPD). Profil is very experienced in handling regulatory submissions both to Competent Authorities such as the Federal Institute for Drugs and Medical Devices ("Bundesinstitut für Arzneimittel und Medizinprodukte", BfArM) and the German Ethics Committees. Dedicated staff and expert consultants with long-standing experience in CTA submissions thoroughly review the submission package and identify critical topics early, so that these can be addressed before submission. With this procedure, delays in the approval process can be minimised or avoided at all.
In total, more than 100 studies were submitted by Profil to BfArM and/or German ECs after implementation of the Clinical Trials Directive 2001/20/EC. With the broad experience gained in these submissions and in frequent discussions with regulatory bodies (including participation at EMEA Scientific Advice sessions), approval times could be shortened to 50 days or less.