About

CHITRA SHARMA

Founder and President

Chitra Sharma is a Technical Consultant with over 15 years experience in pharmaceutical development of small and large molecules. Chitra has specific experience in late stage product development, quality and regulatory strategy areas. She takes on projects that need a strong analytical focus in Method Development and Validation, sets Quality policies that help stay in compliance and strengthens internal resources with product specific needs for Client organizations.

She has authored and reviewed submissions and led several inspections by US FDA, EMA, ANVISA, TFDA, K-FDA, Canadian, Russian Ministry and the Japanese Agency. She has trained and led PAI preparedness teams at client, CMO and partner sites, internationally. Chitra has worked with companies to get them inspection ready as facilities and sites, globally, and has also worked on solution focused Inspection responses and actions for outcomes such as “483” Observations, Warning letters. She also works on Quality investigations, Counterfeit investigations, Field Alerts and Product recalls routinely.

Chitra previously worked at Vivus, Genentech, Cor Therapeutics, Roche BioSciences and Boehringer Ingelheim. She holds a MS in Pharmaceutical Sciences from the University of Connecticut, Storrs, CT.