NDA CMC Documentation for Drug Development

The NDA is one of the most important documents in the life cycle of a drug development project. A well written and presented NDA can facilitate the timely approval of the application; however, a poorly written and presented NDA can cause delays, and delays are expensive. The Chemistry, Manufacturing and Controls (CMC) Section of the NDA must now be compiled according to the format specified in the ICH Common Technical Document (CTD).

FinnBrit Consulting can advise clients on all NDA CMC (CTD) issues.

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