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, food 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)
- Reproductive toxicology and teratology
- Genetic toxicology/mutagenicity
- Safety pharmacology
- General pharmacology
- ADME (pharmacokinetics)
Other services include:
- Generation of position, technical or white papers
- Good Laboratory Practice (GLP) Consulting
- Due diligence assessments for buy-outs and venture capital investments
- Preparation and review of standard operating procedures (SOP)
- GRAS expert panels
- Generation of manuscripts/abstracts for publication
- Peer review services
- FDA GLP, EPA GLP, OECD GLP, FDA Redbook, and ICH guideline compliance monitoring
- Data qualifications for Japanese submissions
- F-value (CPSC) Assessments
- Fraud Vulnerability Assessments
- Threshold of Regulation assessments
- Litigation Support
- MSDS Preparation
- Staff training for SOP reviews and GLP training
- Scientific literature searches
- Electronic submissions (e-submissions)
As a team, we are a full service company providing Regulatory, Statistical, CMC (Chemistry, Manufacturing and Control), Pathology, Clinical and Formulations expertise to resolve issues and submit entire regulatory dossiers.
Robin Guy, the principal toxicologist, is a Board Certified Toxicologist (Diplomate of the American Board of Toxicology, DABT) with over thirty years experience in toxicology and product safety assessment, including designing and coordinating toxicology studies in addition to providing scientific and regulatory expertise.
Each and every client is important. Therefore, individual attention is given to every client. Robin Guy Consulting, LLC can assure clients absolute confidentiality.