In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the quality and consistency of pharmaceutical products. The quality portion of a submission (such as an IND, NDA, BLA, MAA, etc.) varies in complexity based on the synthesis route of the drug substance/active pharmaceutical ingredient (API) and the type of drug product (oral solid, oral liquid, topical, parenteral, etc.).
CMC documentation describes the methods and standards used in the manufacture and control of drug substances and drug products. This meticulous documentation is critical for regulatory submissions as it demonstrates that a pharmaceutical product meets safety, efficacy, and quality standards.
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