REGEXBIO provides REGulatory EXpertise in BIOlogicals for the development of your biopharmaceutical.

Key deliverables on your CMC timeline are heavily influenced by regulatory requirements. These can be generated to a high quality and right first time by applying knowledge and experience of working in the area both within the Chemistry Manufacturing and Control (CMC) and Regulatory Affairs (RA) functions. Every technical Subject Matter Expert will have some regulatory knowledge, and some regulatory experts may have some technical knowledge. Bridging these two knowledge bases can provide invaluable input on your product development, and a seamless interface in the interpretation of CMC data for the delivery of strategy, gap analyses, technical reports and dossiers.