CroToxPath is a consultancy consortium based in Toronto, Canada. CroToxPath is made up of a team of professionals with significant combined experience in toxicology, pathology, safety assessment, regulatory toxicology, and project management skills. CroToxPath provides consulting services to a Pharmaceutical and Biotechnology companies ranging from an early development of nonclinical safety assessment strategies to support discovery efforts (e.g., lead selection), to the First-in-Human programs and advanced development/registration for small NCE and biologics.

CroToxPath helps with the design of tailored nonclinical programs, interpretation of toxicological issues, preparation of regulatory documents, regulatory scientific advice procedures, direct management and monitoring of toxicology studies, and assessment of critical safety issues of the drug products.

We have experience in many routes of administration including oral, dermal, intravenous and inhalation and the team’s background includes such disciplines as biochemistry, clinical pathology, pathology, safety pharmacology, veterinary medicine, ADME/pharmacokinetic analyses, toxicology, genotoxicology and broad understanding of the pharmaceutical drug development process. The team has experience in therapeutic areas such as GI, infectious disease, CNS areas, cancer, diabetes, metabolic diseases, Parkinson’s disease and other neurodegenerative diseases, hypertension, immunomodulators, vaccines, orphan diseases, etc.

In addition, we also offer a pathology peer review when important risk assessment or business decisions are based on nonclinical studies. For pathology peer review conducted before study completion, the peer-review pathologist reviews sufficient slides and pathology data to assist the study pathologist in refining pathology diagnoses and interpretations.

CroToxPath can also offer safety evaluation and monitoring of toxicological studies on veterinary medicines, chemicals, agro-chemical products and food additives in accordance with their respective regulations.

We make sure that all the nonclinical safety studies performed for our customers are fully compliant with the Good Laboratory Practice regulations (GLP) as required.

And finally, we can assist companies conducting their research business in Canada with the Canadian Scientific Research & Experimental Development Tax Incentive Program (SR&EDs), and to protect their intellectual properties in the EU countries.