TBD CMC documentation
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Service overview

Compilation of Regulatory Documentation (ASMF)

Regulatory documentation packages, like the Active Substance Master File (ASMF) in the EU or the Drug Master File (DMF) in the US, provide comprehensive data on API quality and manufacturing. These documents are submitted to health regulatory agencies to facilitate the API’s registration and approval process. Serving as key resources for assessing API quality and safety, these master files are instrumental in streamlining the approval and commercialization steps within the generic GMP API development pipeline.

ASMF compilation and support

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