Nancy J. Chew, M.S., RAC, FRAPS
Areas of Expertise: Food & Drug
Internationally recognized FDA regulatory affairs expert, Nancy Chew has provided regulatory services for over 40years. She began forensic consulting in the 1980's when she was asked to advise the litigants in the Bolar case. She has substantial experience with securities litigation of FDA-regulated products.
Specialty Focus: Pharmaceutical and biotechnology regulation requirements, product development, FDA regulatory liaison, regulatory submissions, clinical research applications (INDs), drug marketing applications (NDAs), FDA approvals, US agent for FDA matters.
Author, lecturer, teacher, consultant and recipient of several professional society awards, Nancy has helped large and small companies bring products to market for more than 40 years. She has supported litigation for more than 30 years.