regulatory submission support

CMC Pharma is a small molecule contract development and manufacturing organization (CDMO) providing end-to-end CMC (Chemistry, Manufacturing, and Controls) drug development services. It offers formulation and process development, analytical chemistry, ICH stability and compatibility testing, method transfer, scale-up and tech transfer, CMO selection and oversight, and integrated regulatory support for IND/NDA submissions. The company operates cGMP laboratories and a pilot plant for non-GMP small batch production but does not own a commercial GMP manufact

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analytical method development and validationcGMP complianceCMO management and oversightcompatibility assessmentsdissolution studiesforced degradation studiesformulation developmentICH stability testingmethod transferpilot plant small batch productionprocess developmentrelease testingscale-uptech transfer