CBR Biotech Strategies GmbH Information

CBR Biotech Strategies GmbH specializes in the development and E.U. representation for biotech, pharmaceutical and medical device companies. Our principal consultant, with over 15 years of experience working with U.S. and international clients, can assist with the strategic and tactical planning for FDA and E.U. interactions. These include teleconferences and meetings, such as pre-BLA and EOP II meetings, and the preparation and submission of drug applications to the FDA and other regulatory agencies worldwide. As authorized representatives in the European market, CBR Biotech Strategies GmbH can provide support through our skilled Ph.D. scientists with over 50 years of combined regulatory experience. We have considerable experience with European regulatory representation for the biopharma and pharmaceutical industries. With a myriad of development programs including biologics, antibodies, small molecules and medical devices, CBR Biotech Strategies GmbH specializes in the preparation, compilation, and publication of eCTD submissions for the U.S. and European markets. In addition, the experts at CBR Biotech Strategies GmbH can provide training on the basics of eSubmissions and determine a client's eCTD readiness. CBR Biotech Strategies does more than audit systems, we build systems. We are not simply consultants, we are an extension of YOUR team in global development and strategy. We are not just regulators, we are scientists who understand what regulatory agencies require for product development and approval. Everything we do is customized to YOUR needs with regard to your stage of development, financial planning and corporate goals.