Robin Guy Email & Phone Number

I have worked full time as a consultant for Robin Guy Consulting, LLC for twenty-one years now. Prior to that, I had 19 years in the pharmaceutical and food ingredient industries. Robin Guy Consulting is a professional consulting company specializing in preclinical toxicology, product safety assessment, and GLP consulting and training. Clients range from other consultants and start-up companies to universities and Fortune 500 corporations. Clients encompass the pharmaceutical, biologic, biotechnology, gene therapy, wound care, food additive, food ingredient, flavor, flavor modifier, dietary supplement, and pesticide industries. I have experience with small and large molecules, nanoparticles, nanomaterials, and botanicals. I perform safety/risk assessments for main products, excipients, contaminants, degradants and metabolites. The majority of my clients are trying to get FDA regulatory approval for their products (IND, BLA, NDA, FAP, GRAS, FCN, etc.). I help laboratories get up to GLP quality. I lead/teach GLP training (FDA, EPA and OECD) for companies and individuals worldwide, both in-person and remote. I perform Quality Assurance Audits for GLP studies/labs. Clients also encompass Insurance, Venture Capitol and companies needing assistance with nonclinical due diligence for acquisitions. I have a large network of other scientist and professionals who can work together to get entire projects, including regulatory submissions, completed with successful results.Specialties: Toxicology & non-clinical studies (design and monitoring)FDA regulatory Submissions (IND, NDA, 505(b), eCTD, FAP, FCN, GRAS, NDI, Impurity qualification)"F-value" estimates for CPSC packagingSENDDue diligence nonclinical auditsQuality Assurance GLP AuditsGLP TrainingAssist laboratories to get to GLP qualitySetting up brand new laboratoriesPerform Fraud Vulnerability Investigative Assessments, data integrity audits/inspectionsConduct GLP Mock InspectionsTraining & research to correct violations, FDA 483s, and warning letter issues

Listed skills include Glp, Fda, Toxicology, Regulatory Submissions, and 45 others.

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  University Of Illinois Urbana-Champaign

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