With the institutional license now in place, Nutrasource says its clients will have an accelerated path to cannabis human research authorisations
Nutrasource Pharmaceutical and Nutraceutical Services has announced it’s now an official Institution-Wide Cannabis Research License holder under the Cannabis Act, having obtained approval from Health Canada’s Controlled Substances and Cannabis Branch.
With the institutional license now in place, Nutrasource says its clients will have an accelerated path to cannabis human research authorisations, a process which has previously involved uncertain and prolonged timelines when submitting individual projects on a stand-alone basis. These delays drove up costs for product development and claims substantiation related to safety and efficacy.
This Institution-wide Cannabis Research License allows Nutrasource to expedite government approvals to do human research at the Nutrasource site without applying for multiple licenses each time a study is conducted. It will also be able to run multiple research projects at the same site for various clients simultaneously; and conduct clinical and efficacy trials, sensory pharmacokinetic, pharmacodynamic and palatability studies.
“This license is pivotal for our client base given that regulatory approval delays in this product category have been unpredictable, which adds substantially to the client’s project timelines and cost,” said William Rowe, President and CEO of Nutrasource.
Joshua Baisley, VP of Clinical Trial Design & Delivery said: “As leaders in providing clinical trial services to the global cannabis industry, this institution-wide license adds additional benefit to the favourable Canadian regulatory environment, including (CTA) Clinical Trial Applications for human studies in this expansive product category. We are proud to be the first privately held and independent CRO that has been granted this type of license for human research from Health Canada.”