Generally Recognized As Safe . . .
WELCOME
20482 Jacklight Lane 541-678-5522
Bend, OR 97702-3074 mcquate@gras-associates.com
www.gras-associates.com
Robin C. Guy, M.S., DABT
Biography
Over twenty-six years designing and coordinating toxicology studies and preparing regulatory submissions in addition to providing scientific and regulatory expertise in toxicology, which includes nineteen years in industry (pharmaceutical toxicology and food ingredient safety assessment) and has been an independent consultant since 2000.
Robin has been a toxicology consultant for over 7 years for Robin Guy Consulting, LLC. Prior to consulting, Robin was in industry with Monsanto/The NutraSweet Company/Searle for 19 years. Robin's activities in toxicology have centered on the safety assessment and regulatory approval of food ingredients and pharmaceutical compounds, including small and large molecules and botanicals. She assisted with aspartame defense, reaffirmations and approvals worldwide. She also was key in the nonclinical development of Neotame, in addition to working on the preparation of the two food additive petitions. Robin has served on GRAS panels and attends FDA meetings. She is a Diplomate of the American Board of Toxicology. Robin is a member of the American College of Toxicology, the Society of Toxicology, the Midwest Chapter of the Society of Toxicology (MRC/SOT), the Roundtable of Toxicology Consultants (currently President), the Institute of Food Technologists (IFT) and the Society of Toxicology Canada.
Robin has been a toxicology consultant for over 7 years for Robin Guy Consulting, LLC. Prior to consulting, Robin was in industry with Monsanto/The NutraSweet Company/Searle for 19 years. Robin's activities in toxicology have centered on the safety assessment and regulatory approval of food ingredients and pharmaceutical compounds, including small and large molecules and botanicals. She assisted with aspartame defense, reaffirmations and approvals worldwide. She also was key in the nonclinical development of Neotame, in addition to working on the preparation of the two food additive petitions. Robin has served on GRAS panels and attends FDA meetings. She is a Diplomate of the American Board of Toxicology. Robin is a member of the American College of Toxicology, the Society of Toxicology, the Midwest Chapter of the Society of Toxicology (MRC/SOT), the Roundtable of Toxicology Consultants (currently President), the Institute of Food Technologists (IFT) and the Society of Toxicology Canada.
FDA Experience
- Assisted with aspartame defense and re-affirmation while at the NutraSweet Company
- Participated in GRAS review of several ingredients
- Managed self-GRAS justifications for food ingredients, including defoaming agents
- Participated in the product development and preparation of food additive petitions for Neotame
- Interact with CDER on pharmaceutical products and impurities for clients
- Consult on GRAS status
- Conduct Good Laboratory Practice audits of laboratories for compliance with GLP regulations
- Manage preclinical packages for submission to the FDA
- Monitor nonclinical studies for FDA submission
- Prepared dozens of INDs and participated in writing some NDAs for FDA approvals
Complete Resume Available Upon Request
