toxicology, GLP  and product safety consulting and training
Preclinical Toxicology and Safety Studies & Project Management
We design toxicology programs starting with range finding studies which lead to Investigational New Drug (IND) enabling studies, New Drug Applications (NDAs), GRAS submissions, New Food Ingredients, and Food Additive Petitions (FAPs).
We forge through to the cost and time efficient path, NOT necessarily the path the Contract Research Laboratories (CROs) want you to take.
We will investigate and provide guidance for FDA GLP, FDA CDER, FDA CFSAN (including FDA Redbook), OECD and ICH regulation/guideline compliance. We effectively design protocols, initiate, monitor and report GLP and range-finding preclinical studies. If requested, we place studies with a reliable worldwide network of contract research laboratories (contract research organizations, CROs).
Our vast experience is utilized in designing and monitoring preclinical animal studies for pharmaceutical and food applications, including:
  • general toxicology (acute to repeated dose)
  • carcinogenicity (with or without in utero phase)
  • reproductive toxicology
  • teratology
  • in vitro and in vivo genetic toxicology
  • safety pharmacology
Services are also available for auditing and reviewing studies conducted internally or at outside laboratories (Quality Assurance Audits and Reports) by a RQAP-GLP professional (GLP expertise).

Clients may also request laboratory GLP facility audits (see GLP Consulting page). Due-diligence audits are also performed for nonclinical studies and programs.
Robin Guy Consulting, LLC also is available to provide a leadership role on project management teams in evaluating and interpreting the safety of existing and potential products. We summarize and present toxicology and other nonclinical data to facilitate critical decisions for the development, acquisition and commercialization of potential products.
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