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CMC Compliance

Meaning

CMC Compliance signifies the rigorous adherence to comprehensive regulatory requirements governing the Chemistry, Manufacturing, and Controls aspects of a drug or biological product throughout its lifecycle. In the context of hormonal therapeutics, this ensures the identity, strength, quality, purity, and long-term stability of hormone preparations, including both synthetic and bioidentical compounds. Achieving and maintaining CMC compliance is a non-negotiable prerequisite for obtaining regulatory approval and ensuring the predictable clinical performance of any medicinal agent.