CMC and the Critical Path to NDA: The Journey from Molecule to Market
The Premier Consulting Blog
DECEMBER 10, 2024
Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Validation involves detailed documentation of every step of the production process, from raw material sourcing to final product packaging in good manufacturing practice (GMP) compliant facilities.
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