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| Name and Educational Degree: |
| University of Illinois '81 |
Robin Guy Consulting, LLC
P.O. Box 830
Lake Forest, Illinois 60045
USA |
| Toxicology and product safety assessment, Product development, Protocol design (GLP and non-GLP), Preclinical study placement and monitoring, GLP facility audits (in-house or CRO), Data auditing, Report review and preparation, Study summary tables, Preparation of toxicology submissions (Food Additive Petitions, IND, annual reports, NDA, CTD format) for FDA and internal documentation, Expert panel participation/organization, GRAS review, Position/white papers, Risk assessments, Qualification of data for Japanese submissions, Product/project management, GLP training, MSDS preparation. |
| Specializing as a toxicologist in a GLP-regulated environment since 1982; including 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); consulting since 2000. Extensive experience writing regulatory submissions, and auditing preclinical studies and CROs. Memberships: Roundtable of Toxicology Consultants (President '07-09, President-elect '05-'07, Secretary '03-'05); American College of Toxicology (elected positions: Long term Planning Committee ('05-08), 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: President '06-'07, President-elect '05-'06, Councilor '02 – '04, Secretary); Society of Toxicology (Career Resourse and Development Committee '06-'08); Society of Toxicology Canada; Society of Quality Assurance; MWSQA; Regulatory Affairs Professional Society; American Chemical Society. |
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