Due Diligence Assessment of CMC Activities

October 16, 2020
William J. Lambert

William J. Lambert, PhD, is principal, Module 3 Pharmaceutical Consulting, Incline Village, NV.

BioPharm International, BioPharm International-10-15-2020, Volume 2020 eBook, Issue 3
Page Number: 42–44

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

Read this article in BioPharm International’s Regulatory Sourcebook October 2020 eBook.

Article Details

BioPharm International
eBook: Regulatory Sourcebook
October 2020
Pages: 42–44

Citation

When referring to this article, please cite it as W. Lambert, “Due Diligence Assessment of CMC Activities," BioPharm International Regulatory Sourcebook eBook (October 2020).