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| Name and Educational Degree: |
| University of Illinois '81 |
Robin Guy Consulting, LLC
P.O. Box 830 Lake Forest, Illinois 60045
United States |
| Telephone: |
(847) 295-9250 |
| Fax: |
(847) 295-9251 |
| Email Address: |
rcg@robinguy.com |
| Web Site URL: |
http://www.robinguy.com |
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- 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.
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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 (Past President '09-'11, President '07-09, President-elect '05-'07, Secretary '03-'05);
- American College of Toxicology (elected positions: Vice President ('11-'12), 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 (Education Committee '09-'11, Career Resourse and Development Committee '06-'08);
- Society of Quality Assurance;
- MWSQA;
- Regulatory Affairs Professional Society;
- American Chemical Society.
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