Nancy Chew, Regulatory Affairs, North America, Inc.
3337 Lassiter Street Durham, NC 27707
(919) 949-4617 - Fax: (919) 321-6104
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.