Robin Guy Consulting

Robin Guy Consulting, LLC is a professional consulting company specializing in preclinical toxicology, product safety assessment, quality assurance and GLP consulting and training. Clients range from other consultants and start-up companies to Fortune 500 corporations. Clients encompass the pharmaceutical, biologic, biotechnology, medical device, f... ood additive, food ingredient and dietary supplement industries, and universities. We have experience with small and large molecules, nanoparticles and nanomaterials, as well as botanicals. We are a full service company. We provide nonclinical, and product safety assessment guidance leading to potential product commercialization or acquisition. In addition, we collaborate with clients to evaluate and interpret the safety of existing and potential products, metabolites and degradants. Robin Guy Consulting also provides Quality Assurance and Good Laboratory Practice (GLP) consulting. We prepare entire regulatory submissions for pharmaceuticals, food ingredients and medical devices. These can be hardcopies or electronic submissions (e-submissions). We also specialize in preparing toxicology and nonclinical summaries, or entire submissions for: Regulatory submissions for FDA and worldwide agencies including: Investigational New Drugs (IND) New Drug Applications (NDA) using the Common Technical Document (CTD) format IND Annual Reports Investigational Device Exemption (IDE), 510(k) Premarket Notifications and Premarket Approval (PMA) Food Additive Petitions (FAP), and Food Contact Notification (FCN) GRAS (Generally Recognized as Safe) Determinations Clinical Trial Application and New Drug Submission (TPD, Health Canada) Clinical protocols submitted to an Institutional Review Board (IRB) Investigator's Brochures (IB) Management reports, investor and venture capital information and due diligence assessments We utilize our vast experience in designing and monitoring GLP and non-GLP preclinical studies, including: General toxicology (acute and repeated dose) Carcinogenicity ...Read More