A Contract Manufacturing Organization (CMO) is a third-party company that manufactures drugs, biologics, or medical devices on behalf of a sponsor.
CMOs commonly produce investigational product for clinical trials and may also support commercial-scale manufacturing after approval. Their work includes formulation, fill-finish, packaging, labeling, and quality testing under established specifications. Because clinical supply continuity depends on reliable production, CMOs directly influence enrollment timelines and site operations. Compliance with Good Manufacturing Practice (GMP) requirements is essential for regulatory acceptance and participant safety.