Contact Information

  • Company: Regulatory Affairs, North America, Inc.
  • Phone: 919 949 4617
  • Website: www.ranainc.com
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Specialties & Experience

General Specialties: Pharmaceutical Regulation

Specialty Focus: FDA, Food and Drug Administration, 21 U.S.C. and 21 CFR, Investigational New Drug Applications, New Drug Applications, FDA-regulated product development and registration,regulatory affairs practice, FDA regulated industry, submissions/dossiers,labeling, compliance.

Education: M.S., Florida State University; B.A. , Woman's College University of North Carolina

Years in Practice: 35+

Number of Times Deposed/Testified in Last 4 Yrs: 1


Additional Information

Specialty Focus: FDA regulatory requirements, Product development strategy, FDA-regulated product development, FDA regulatory liaison, regulatory submissions, clinical research applications (INDs), drug marketing applications (CTDs, NDAs), FDA approvals, US agent for FDA matters. Education: M.S. Physiology, Florida State University, 1968. B.A. Biology, Woman's College of the University of North Carolina, 1963. Years in Practice: 35+ Additional Information  Certified regulatory affairs expert with over 35 years experience in pharmaceutical regulatory affairs.  Significant teaching experience in the pharmaceutical and regulatory field, and lectures frequently on regulatory matters.  Published in technical journals, magazines, books, articles, and columns in the regulatory and pharmaceutical fields.  Member of the Scientific Advisory Board for BioLink Sciences, Inc.  Holds a regulatory affairs certification and is a fellow of the Regulatory Affairs Professionals Society (RAPS).  Co-creator of the Regulatory Affairs Professionals Society’s regulatory affairs credentialing (RAC)program.  Recipient of the Richard E. Greco Regulatory Affairs Professional Award, and the Leonard J. Stauffer Award for Mentoring, Regulatory Affairs Professional Society.  Past chair of the Regulatory Affairs Professional Society credentialing board.  Past Vice President of Education and Membership for the Regulatory Affairs Professional Society.  Past president of the North Carolina Regulatory Affairs Forum.  Fellowships Completed: o Predoctoral fellowship in Biochemistry from Cornell University Medical College. o Public Health Service predoctoral fellowship from the National Institute of General Medical Sciences at Florida State University. o Florida State University Teaching Fellowship