RTCTox Research & Technology Center in Toxicology

Pill Identification

Robin Guy, M.S.

Expert Toxicology Consultant / Toxicologist
	Food Ingredients/Additives Dietary Supplements Redbook Pharmaceuticals Preclinical Study Monitoring FDA Submissions: IND, NDA, FCN, GRAS Diplomate, American Board of Toxicology
Areas of Toxicology Expertise:
	Pharmaceutical and Food Ingredient Toxicology Toxicology and Product Safety Assessment Protocol Design (GLP and Non-GLP) Preclinical (Nonclinical) Study Placement and Monitoring GLP Facility Audits (in-house or CRO) Data Auditing Report Review and Preparation Study Summary Tables Preparation of Toxicology Submissions including Food Additive Petitions, FCN, IND, Annual Reports, CTD, NDA) for FDA and Internal Documentation Expert Panel Participation/Organization GRAS Review Position/White Papers Risk Assessment Qualification of Data for Japanese Submissions Product/Project Management GLP Training
Description:
	Twenty-one years of Toxicology Experience; 8 years in Industry with Pharmaceuticals, 11 years in Industry with Food Additives/Ingredients and Dietary Supplements (Worked on Neotame Project from Start to Submission to the FDA) and 3 years Consulting. American College of Toxicology Elected Positions: Membership Committee '01-'04, Nominating Committee '00 -'01, Secretary '98 - '00, Councilor '94 - '97. Midwest Regional Chapter - Society of Toxicology Elected Positions: Councilor ’02 – '04, Secretary Board Certified Toxicologist. Twenty-three years of Toxicology Experience; 8 years in Industry with Pharmaceuticals, 11 years in Industry with Food Additives/Ingredients and Dietary Supplements (Worked on the Sweetener, Neotame, from Start to Submission to the FDA) and 4 years Consulting.
Contact information
	Robin Guy, M.S. Robin Guy Consulting, LLC P.O. Box 830 Lake Forest, Illinois 60045-0830 Phone: (847) 295-9250 Fax: (847) 295-9251 Home Page: http://www.robinguy.com, http://ToxConsultant.com Email: rcg (at) robinguy.com Website:http://rtctox.com/guy.htm
Professional Memberships:
	Associations: American College of Toxicology Elected Positions: Membership Committee '01-'04, Nominating Committee '00 -'01 and ’04-’05, Secretary '98 - '00, Councilor '94 - '97. Midwest Regional Chapter - Society of Toxicology Elected Positions: Councilor ’02 – '04, Secretary. Institute of Food Technologists. Regulatory Affairs Professional Society.
Litigation Toxicology Expert Witness:
	Willing to serve on a limited basis as an Expert Witness


Dictionary of Abbreviations and Acronyms used:
Cro	Contract Research Organization
Ctd	Comparative Toxicogenomics Database
Fcn	Food Contact Notification
Glp	Good Laboratory Practice
Gras	Generally Regarded as Safe
Ind	Investigational New Drug
Nda	New Drug Application

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