From March 6-8 of 2019, Nucro-Technics was audited by the Standards Council of Canada (SCC) to maintain its GLP certificate of recognition. This audit was conducted against the OECD GLP standards. GLP regulatory audits occur periodically for all CROs and for Nucro-Technics the assessments have been every two years. Over the three days that the audit team was on-site, documentation relating to pre-clinical toxicology, bioanalytical and genetic toxicology GLP studies conducted at Nucro-Technics was reviewed. These GLP studies are part of an IND (or other) regulatory application and are submitted through to the FDA and other regulatory agencies. As with the previous GLP audits conducted by the SCC, a compliant rating was maintained.
Although the audit itself took only three days, the process of closing it out takes more time. Many people need to review the inspection report and responses before signing it off. With that being said, Nucro-Technics’ Certificate of Recognition was updated to reflect the audit close-out and we have updated our downloadable accreditations.
Nucro-Technics is Your Contract Research Partner
If you are a company at the non-clinical stage looking to submit an IND application to the FDA or to other regulatory agencies, Nucro-Technics can help you. Nucro-Technics has been in business since 1970 and has been testing novel molecules and products for the pharmaceutical, biotech, and medical device industries from the very beginning. We offer a full array of services that cover testing from the benchtop through efficacy, in vitro genetic toxicology, in vivo pharmacokinetic and safety, through to clinical trials and beyond. Non-clinical work conducted by Nucro-Technics that is submitted to regulatory agencies is conducted in compliance with Good Laboratory Practices (GLP).