Senior CMC Consultant at Biologics Consulting Group, Inc.
Nadine M. Ritter,Ph.D., senior consultant for Biologics Consulting Group, Inc., is a protein chemist with expertise in the chemistry, manufacturing and control (CMC) of biotechnology products. She is past Director of Analytical Services Division at major contract testing organization performing R&D, GLP and GMP analytics studies. For over 15 yrs, she has contributed data to numerous US and international regulatory IND/IMP and BLA/NDA/MAA filings.
She also has considerable experience conducting audits of sponsor and contract laboratories worldwide. She is a member of several professional analytical organizations, and is frequently invited as a speaker and writer on analytical and stability issues.