Scientific Research and Consulting
Location: Colorado USA
Area Served: Continental United States

Services Available

Technical Regulatory Affairs

• Research scientific literature for patent preparation, review and prior art evaluation.
• Develop evidence for self-affirmation of GRAS (Generally Regarded As Safe) status.
• Prepare product health claims according to the Food and Drug Administration Modernization Act.
• Prepare pre-market notification for new dietary ingredients.
• Provide technical assistance for response to Federal Trade Commission access letters.

Product Development and Marketing

• Analyze new technologies for product development feasibility.
• Review raw materials and finished products.
• Formulate dietary supplements and functional foods.
• Evaluate marketing claims for FDA and FTC compliance.
• Prepare and review labels and marketing claims.
• Review protocols for safety and efficacy trials

Additional Services

• Library and database research for fact-finding.
• Prepare detailed research reports and data analyses.
• Nutritional evaluation and counseling.  

Qualifications

Twenty four years of biochemical, pharmaceutical and nutrition research experience in industrial and academic settings. Includes four years of technical regulatory affairs in the nutritional supplement industry.

SELECTED PUBLICATIONS
List available from ADMIN@proexperts.org