| Robin Guy Consulting, LLC is
a professional consulting company specializing in preclinical
toxicology, product safety assessment and GLP 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. We have experience
with small and large molecules, nanoparticles and nanomaterials,
as well as botanicals. |
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We are a full service company. We provide nonclinical,
clinical 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.
We prepare
entire regulatory submissions for pharmaceuticals, food
ingredients and medical devices. These can be hardcopies or
electronic submissions (e-submissions). |
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| We also specialize in preparing toxicology and
nonclinical summaries, or entire submissions for: |
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Regulatory submissions for FDA and
worldwide
agencies including: |
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Investigational New Drugs (IND) |
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New Drug Applications (NDA) using the Common Technical Document (CTD) format |
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IND Annual Reports |
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Investigational Device Exemption (IDE), 510(k)
Premarket Notifications and Premarket Approval (PMA) |
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Food Additive Petitions (FAP), and Food Contact Notification
(FCN) |
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GRAS
(Generally Recognized as Safe) Determinations |
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Clinical Trial Application and New Drug Submission (TPD, Health
Canada) |
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Clinical protocols submitted to an Institutional
Review Board (IRB) |
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Investigator's Brochures (IB) |
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Management reports, investor and venture captial
information and due diligence assessments |
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| We utilize our vast experience in designing and
monitoring GLP and non-GLP preclinical studies, including: |
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General toxicology (acute
and
repeated dose) |
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Carcinogenicity |
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Reproductive toxicology and teratology |
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Genetic toxicology/mutagenicity |
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Safety pharmacology |
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General pharmacology |
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ADME (pharmacokinetics) |
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| Other services include: |
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Generation of position, technical or white papers |
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Due diligence assessments for buy-outs and venture
capital investments |
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Preparation
and review
of standard operating procedures (SOP) |
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GRAS expert panels |
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Generation of manuscripts/abstracts for publication |
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Peer review services |
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FDA GLP, EPA GLP, OECD GLP, FDA Redbook, and
ICH guideline compliance monitoring |
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Data qualifications for Japanese submissions |
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Threshold of Regulation assessments |
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Litigation Support |
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MSDS Preparation |
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Staff training for SOP reviews and GLP training |
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Scientific literature searches |
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Electronic submissions (e-submissions) |
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| 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. |
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| Robin Guy, the principal toxicologist, is a Board
Certified Toxicologist (Diplomate of the American Board of
Toxicology,
DABT) with over twenty-five years experience in toxicology
and product safety assessment, including designing and coordinating
toxicology
studies in addition to providing scientific and regulatory
expertise. |
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| Each and every client is important. Therefore,
individual attention is given to every client. Robin Guy Consulting,
LLC can assure clients absolute confidentiality. |
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