Bryanek Regulatory Ltd

Providing CMC regulatory consulting from the historic heart of Cornwall. Meeting your requirements either on-site or remotely. Seven years proven track record of providing excellent service to clients from remote offices through teleconferencing. You can be confident of the quality of work, whether based on-site or remotely at the Bryanek Regulatory Cornwall office. Preparation of Global regulatory strategies Manufacturing site rationalisation (site transfers) International CMC variations EU Post Marketing Applications Authoring Module 3 documentation CMC authoring experience with drug products and drug substances Ensuring compliance with current regulatory requirements and standards Gap analysis and Compliance projects Review of CMC data Renewals Responding to regulatory authority questions To discuss any other requirements you may have, please get in touch.