Nutrasource Pharmaceutical and Nutraceutical Services, a global contract research organisation (CRO), has announced the approval of an amendment to its Controlled Drugs & Substances Dealer’s Licence issued by Health Canada earlier this year. The licence has been expanded to include a number of controlled Psychedelic and Psychostimulant drugs and pain management drugs including but not limited to, psilocybin, psilocin, ketamine and LCD, as well as methamphetamines, synthetic cannabinoids, opioids and DMT.
The Security Level 5 Licence allows clinical trials for safety, tolerability, characterisation and efficacy for an expanded list of controlled drugs and substances. Approval will afford the company's clients an opportunity to conduct early stage clinical studies, including bioavailability and bioequivalence studies, in addition to proof of concept studies with a range of controlled substances.
The CRO says there's an increased interest from the pharmaceutical and biotechnology industries in opioid alternatives and drugs of abuse, along with other agents related to the central nervous system and neurology for mental health conditions.
“This initiative is a natural progression building and diversifying our portfolio of licences including our Institution-Wide Cannabis Research Licence and Cage Level Security Licence. We are pleased to continue supporting our current and future clients in the areas of pharmaceutical development with botanical agents, psychedelics, and opioid alternatives” said Joshua Baisley, VP, Clinical Design and Delivery.
“Working with Sponsors in the Natural Health Product industry, we often see a transition into the pharmaceutical space as an avenue for innovation. Obtaining this licence further fulfills Nutrasource’s mission of helping health companies launch scientifically substantiated products and aligns with our expanded pharmaceutical regulatory services,” said Tania John, VP, NHP & Pharmaceutical Regulatory Sciences. “Ultimately, this higher level of security allows us to better serve our clinical and regulatory clients, including those interested or already in the controlled drugs and substances sector.”
