CMC
Chemistry, Manufacturing, and Controls — the quality module of a regulatory dossier.
What it means
CMC stands for Chemistry, Manufacturing, and Controls. It is the section of a regulatory dossier that describes the composition, manufacturing process, quality controls, and stability of a drug or biologic. For marketing authorization submissions, CMC documents must be translated into the local language and aligned with local pharmacopeia and regulator conventions.
Why it matters for LATAM submissions
CMC translations contain precise technical and quality language. Errors in specifications, manufacturing steps, or stability data can delay approval or trigger post-approval commitments.
Relevant regulators
Related terms
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