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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