The Chemistry, manufacturing, and control (CMC) testing of drug substances play a critical role guaranteeing the quality of the drug product entering clinical trials. The main aspects of the quality development include the following activities:
- Generation or review of a CMC development plan to support global development.
- Technical CMC input including, but not limited to, manufacturing process development and validation, product characterization, assay development, control strategy and stability.
- Vendor selection and management, including technical review of manufacturing plans.
- Preparation of CMC sections of investigational new drug applications, European filings, applicable drug master files and abbreviated new drug applications.