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Articles by Bob Mehta

Bob Mehta


Bob Mehta is a principal consultant and recruiter at GMP ISO Expert Services www.gmpisoexpert.com and provides consulting service in pharma, biotech, medical device, API, and food/dietary supplement industries, contact@gmpisoexpert.com

Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances
May 2, 2013

The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.

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