Nanda Subbarao, Ph.D.,

Senior Consultant, Biologics Consulting

Dr. Subbarao has been a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems since 2007. Prior to that, she was with Sandoz and Pfizer.  Her consulting areas include GMP systems design and implementation focusing on laboratory and stability systems, data integrity and equipment. She has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products from pre-clinical phase to commercial phases. Some specific technical areas include small molecule pharmaceuticals, well characterized proteins including biosimilars and vaccines.

Nanda has co-authored numerous scientific publications and frequently is an invited speaker at Industry Meetings. She serves on the AAPS Stability Community and AAPS Data Integrity and Security Working Group.  She currently serves as an Editorial Advisor for BioProcess International.

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