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William J. Lambert, PhD, is principal, Module 3 Pharmaceutical Consulting, Incline Village, NV.
For planned acquisitions or licensing, careful analysis of CMC factors ensures no problem areas are overlooked.
Developing comprehensive chemistry, manufacturing, and controls programs are crucial to the success of a drug product. For planned acquisitions or licensing, a careful analysis of these critical factors is vital to ensure no problem areas are overlooked. Strategies for carrying out an effective due diligence exercise are described
eBook: Regulatory Sourcebook
When referring to this article, please cite it as W. Lambert, “Due Diligence Assessment of CMC Activities," BioPharm International Regulatory Sourcebook eBook (October 2020).