Whitepaper: A Practical Guide to Early Phase CMC Writing

Onyx Scientific has helped hundreds of projects, taking lead
compounds through process development, synthesising multi-kilo
batches of drug substance for toxicology studies and preparing for
first-in-human clinical trials. In performing this work, Onyx has gained
a thorough understanding of the regulatory requirements needed to
complete the Chemistry, Manufacturing and Controls (CMC) part of
an Investigational Medicinal Product Dossier (IMPD) or Investigational
New Drug application (IND).

Download the whitepaper to explore practical insights.

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