FDA Regulatory Affairs and Labeling Expert for Dietary Supplements, OTC Drugs, and Medical Devices

Technical Consultant #2036


Expertise

  • Food and Drug Administration Regulations (FDA), in foods, dietary supplements, cosmetics, OTC drugs, pet foods and medical devices.
  • Knowledge of allowable marketing claims for FDA regulated consumer products.
  • Research and consumer health product development.
  • Nutrition evaluation of food products.
  • Product formulation and marketing.

Experience

Undisclosed Company, Owner and Principal, 2001 - Present

  • Providing clients with over 20 years' experience in biochemical, pharmacological and nutrition research in academic and industrial settings.
  • Assay development, technology evaluation, regulatory affairs and product formulation and marketing.
  • FDA regulatory affairs services including labeling and marketing reviews and submissions relevant to foods, dietary supplements, cosmetics, OTC drugs and medical devices.
  • Review technologies for patent potential and consumer product applications.

Boston Market Corporation, Golden, CO, Nutrition & Labeling Manager, 2005 - 2007

  • Managed food product labeling process to ensure compliance with FDA, USDA and FTC regulations.
  • Reviewed global regulatory status and consumer perception of proposed food product ingredients.
  • Assist marketing with program development.

NBTY, Inc., Bohemia, NY, Nutrition Researcher, 2002 - 2004

  • Reviewed new products for safety and regulatory compliance.
  • Reviewed literature for claim and safety data. Serve as FDA, FTC liaison.

NatureSmart, (Whole Foods Market, Inc.), Thornton, CO, Senior Research Scientist, 1997 - 2001

  • Responsible for coordination of research efforts for the corporation's largest direct marketing division including new product formulation, literature research and reporting on nutritional supplements for new and existing products.
  • Provided technical assistance for review of patents and FDA regulations, design of in-house efficacy studies and coordination of committee to streamline the new product development process.

Honors & Publications

Credentials

  • Pharmacologist for the Neuroscience Division of a well-known Pharmaceutical firm.

Academic and Professional Affiliations

  • Rocky Mountain Regulatory Affairs Society (Treasurer)
  • Institute of Food Technologists; Food Law & Regulation Division; Nutrition Division

Publications and Patents

  • Author and Co-Author of many publications (abstracts, symposiums and lectures) presented in peer reviewed journals.

Education

  • B.S. Biophysical Sciences, University of Houston, TX
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