Article
A Customized Regulatory Approach to CMCs
Chemistry, manufacturing and controls strategies differ widely for various pharmaceutical products.
Khanh Ngo Courtney, Ph.D., Element’s senior director of biologics, joins a round table of other industry experts to discuss how these varied approaches are factored into regulatory strategy.
Read the full article in BioPharm International.
By Engaged Expert
Dr. Khanh Ngo Courtney
Dr. Courtney's experience extends from R&D to analytical method development, validation, implementation, method transfer, and optimization of test methods for the cGMP setting per USP and ICH guidelines. She is the General Manager for Element Ann Arbor, an analytical lab in our Life Sciences business. She is a CMC professional in the Biological therapeutic space, and specializes in applying analytical strategies to meet regulatory intent.