CMC Regulatory Affairs
Understanding the nuances of specific regulatory guidance and experience of the differing focus and interpretation of guidelines by national authorities often contributes significantly to the success of regulatory submissions. Kinesis Pharma’s CMC RA consultants employ their “insider” knowledge to determine the relevant CMC regulatory strategy and assure the quality, consistency and technical validity of CMC regulatory documentation. The focus is therefore on constructing a documentation hierarchy which supports the relevant quality sections of regulatory submissions for clinical trial applications ( e.g. IMPD, IND), or applications for marketing authorization (NDA, BLA, ANDAs, MAA) in CTD Module 3 format. In particular, this is CMC documentation which is used to support chemical and pharmaceutical development of the drug substance and drug product. This process requires thorough documentation of the scientifically driven activities which underpin CMC development to provide relevant information for the quality sections of submissions and relevant for the authorities.