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Expert Bio

Primary Area of Expertise

FDA Regulatory Affairs

Expert Witness Profile

Internationally recognized FDA regulatory affairs expert, Nancy Chew has provided regulatory services to pharmaceutical, biotechnology, and medical device manufacturers for more than 40 years. She began forensic consulting in the 1980s.

Specialty Focus: Pharmaceutical, biotechnology, and medical device regulatory testing and data requirements; product development; FDA regulatory liaison; regulatory submissions; Investigational New Drug (research) applications (INDs); New Drug (marketing) Applications (NDAs); FDA approvals and US Agent for FDA matters.

Nancy has directed, written, or contributed to a wide range of regulatory submissions (dossiers): INDs, NDAs, 505(b)(2) NDAs, 510(K)s, and pre-meeting briefing books. She is widely published and is sought after as a speaker, educator, and expert witness.