Research and development activities are the foundation on which companies in the life sciences industry are based. Companies of a very scientific and academic nature tend to neglect the issue of approval. However, it is crucial that manufacturers of gene therapy and cell- and tissue-based products turn their attention to regulatory requirements as early as possible. Approval is essential for gaining access to a market and can make the difference between a company's success or failure.
BioRegio STERN Management GmbH offers companies and new business founders in the life sciences industry in the region free coaching on all aspects of regulatory affairs. Two contacts at BioRegio STERN Management GmbH are available to answer your questions at regular consulting days and by appointment. Professor Christa Schröder and Dr Rainer Canenbley – two certified experts in the approval of medical products – also provide initial consulting on our behalf to check which regulatory requirements you need to meet and the best means of doing so. We support you in every phase of the product development process – from the very early stages, through the creation of documents for clinical studies and approval, to preparation for meetings with the authorities. All issues are, of course, treated with the utmost confidentiality.
Dr. Rainer Canenbley
Prof. Dr. Christa Schröder
E regulatory-affairs [at] bioregio-stern [dot] de