IND-enabling studies conducted in Nucro-Technics’ Toxicology laboratory are compliant with Good Laboratory Practices (GLP) as defined by the OECD and the FDA. The organization has been accredited by the Standards Council of Canada and the Nucro-Technics facility is in compliance with AAALAC, the CCAC, and the Animals for Research Act (Ontario). All IND-enabling studies at Nucro-Technics are captured using validated software. Along with the pivotal safety study and safety pharmacology reports, raw data from all studies and can be exported to the SEND format for electronic submission to the FDA.
Bioassays run at Nucro-Technics are compliant with Good Manufacturing Practices (GMP) regulations as defined by the FDA, Health Canada, and the European Medicines Association. These studies are used to support the release of finished drug product to the market or to justify the use of a lot of raw material in a product formulation and are run in accordance with the USP, European Pharmacopoeia (EP), British Pharmacopoeia (BP), and the Japanese Pharmacopoeia (JP).
Nucro-Technics’ toxicology group is supported by in-house Bioanalytical, Clinical Pathology, and Histopathology services.