Research Licenses for Cannabis, Hemp & their Extracts / Derivatives

Research Licenses for Cannabis (marijuana), Hemp and their Extracts / Derivatives / Oils

Research Licences application for Marihuana / Marijuana / Cannabis / HempUnder the Section 56 Exemption. Also see our web page on our hands-on expertise for Extractions of Cannabis

An idea can turn to dust or magic, depending on the talent that rubs against it. William Bernbach

ICS Inc. prepared all of the documentation & successully submitted two Applications for a Licence to Cultivate Marihuana for Scientific Purposes – the fist of the Research Licences for Marihuana application was for the growing of various strains of hemp & marijuana, then the second application was for research into extraction techniques to optimize the amounts of various cannabinoids (THC, CBD, etc) terpenes / terpenoids, waxes, sterols / sterolins, chlorophyll, and certain other key compounds. All of this was for the resultant extract into a finished product dosage form, to be used in series of human clinical trials here in Canada, as an adjunct treatment / therapy to their present anti-epileptic drugs (AEDs) for children with Dravet Syndrome and adults with severe epilepsy. (or as Health Canada calls extracts “derivatives”).

This was in conjunction with applications we also prepared from scratch for Dealer’s Licence and a Producer’s Licence under the ACMPR-MMPR. It involved the use of CO2 supercritical fluid extraction (SFE), including sourcing the equipment. As such, it also included our GMP Consulting services for active pharmaceutical ingredients (APIs) and for investigational new drug products for use in clinical trials.

We created from scratch, the entire Research Protocol for each of the two Research Applications, detailing (but not limited to):

  • Purpose;
    • .
  • Research Project Scope;
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  • Research Project Methodology;
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  • Detailed Description of the Proposed Location;
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  • Description of the Proposed Security Measures;
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  • Description of the proposed record keeping procedures;
    • .
  • All of our detailed qualifications in the form of a curriculum vitae (CV) listing all formal education, training & experience, with attention paid to this specific industry;
    • .
  • SOP & associated forms / checklists for Security (physical & electronic);
    • .
  • Protocol for Assessment of the Entire Security Program;  (incl. detailed audit report);
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  • Security Clearances through the RCMP (incl. Dale Enright – president of ICS Inc);
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  • SOP & associated documents for the record keeping of the controlled drugs transactions (i.e.: sending the finished product to the clinical trial sites);
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  • Sources of all the starting materials (seeds, plants);

    • .
  • Demonstrate that available funding is in place for the entirety of the research project;  and

    • .
  • Most importantly – letters of support from non-profit associations focused on epilepsy & Dravet Syndrome.

Throughout the process, we learned a lot about all the different techniques, equipment, other input materials, etc. that can be attempted for optimizing yeilds of plants and various compounds of interest within them, including the use of plant tissue cultures. (As a phytopharmaceutical chemist, Mr. Enright was already familiar with carbon dioxide (CO2) supercritical fluid extraction (SFE) for herbs & plant materials  going back to ~1999 (along with other extraction techniques).

Since the end result was for providing the extract in a finished dosage form, we also created from scratch, all of the Quality Assurance (QA) program’s documents (Policies, Protocols, SOPs & associated forms, checklists, tables & labels). This covered Good Production Practices (GPP) under our ACMPR-MMPR services for the cultivation of the cannabis (marijuana) & hemp, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) for the raw extracts termed by Health Canada as Active Pharmaceutical Ingredients (APIs), GMP for turning the APIs / extracts into a diluted finished product for the children & adults, and finally Good Clinical Practices (GCP) for the human clinical trials. 

Why use a consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house?  Please see our web pageWhy Use a Consultantas part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.

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