Mike Montemarano, Associate Editor 02.03.21
Nutrasource Pharmaceutical and Nutraceutical Services, a life sciences company, recently announced that it now holds a Health Canada license for Institution-Wide Cannabis Research under the Cannabis Act, after having obtained approval from Health Canada’s Controlled Substances and Cannabis Branch.
Nutrasource’s clients will now have an accelerated path to cannabis human research authorizations, a process that historically involved uncertain and prolonged timelines when submitting individual projects on a stand-alone basis, the company said. Typically, these delays increased the costs for product development and innovation, as well as claims substantiation related to safety and efficacy.
With the Cannabis Research License, Nutrasource can now expedite government approvals that will allow all human research to be conducted at the Nutrasource site without applying for multiple licenses each time a study is conducted. Additionally, the company will be able to run multiple research projects at the same site for various clients simultaneously, and conduct a variety of studies, including clinical and efficacy trials, sensory, pharmacokinetic, pharmacodynamic, and palatability studies that would include participants.
“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 nad cost,” William Rowe, president and CEO of Nutrasource, said.
“As leaders in providing clinical trial services to the global cannabis industry, this institution-wide license adds additional benefit to the favorable Canadian regulatory environment, including clinical trial applications for human studies in this expansive product category,” Joshua Baisley, VP of clinical trial design and delivery for Nutrasource, said. “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.”
Nutrasource’s clients will now have an accelerated path to cannabis human research authorizations, a process that historically involved uncertain and prolonged timelines when submitting individual projects on a stand-alone basis, the company said. Typically, these delays increased the costs for product development and innovation, as well as claims substantiation related to safety and efficacy.
With the Cannabis Research License, Nutrasource can now expedite government approvals that will allow all human research to be conducted at the Nutrasource site without applying for multiple licenses each time a study is conducted. Additionally, the company will be able to run multiple research projects at the same site for various clients simultaneously, and conduct a variety of studies, including clinical and efficacy trials, sensory, pharmacokinetic, pharmacodynamic, and palatability studies that would include participants.
“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 nad cost,” William Rowe, president and CEO of Nutrasource, said.
“As leaders in providing clinical trial services to the global cannabis industry, this institution-wide license adds additional benefit to the favorable Canadian regulatory environment, including clinical trial applications for human studies in this expansive product category,” Joshua Baisley, VP of clinical trial design and delivery for Nutrasource, said. “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.”