CMC Regulatory assistance

“Chemistry, Manufacturing, and Controls” (CMC) is a specific area of the regulatory sector, including all activities regarding the development, manufacturing and control of a drug.

CMC requires a strict cooperation of different professionals as well as specific in-depth knowledge. It is in fact necessary to be aware and comply with the regulatory requirements – from the development phase up to those concerning manufacturing and clinical trials –, inevitably affecting authorisation procedures and post-marketing.

Thanks to many regulatory experts among its staff and several in-house units dedicated to complementary sectors (e.g. quality, clinical trials, etc.), Di Renzo Regulatory Affairs is able to provide companies with specific assistance.

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