John Simon

Principal Consultant

I have a B.Sc. from the University of Alberta, am a Senior Member of the American Society for Quality, Certified Quality Auditor (CQA) through the American Society for Quality; Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society; and RQAP-GLP certification through the Society of Quality Assurance. I have held a series of management positions in Quality Assurance and Regulatory Affairs and also work as a consultant.

I have had a variety of experience being directly involved in FDA and Health Canada Audits in the areas of Medical Device Manufacturing, Drug Manufacturing and Testing, Drug and Device Establishments and Clinical Trial sites. Over the years I have gained experience with biologics, pharmaceuticals, medical devices, dietary supplements/natural health products and cosmetic ingredients. I have experience with a number of submissions to Health Canada and the FDA.


B.Sc. from the University of Alberta


Regulatory Consultant – TEC Edmonton
President and Principal Consultant – John Simon & Associates Ltd.
Director of Operations – Contract Natural Health Product Manufacturer
Director of Quality Assurance and Regulatory Affairs – Exciton Technologies Inc.
Director of Quality Assurance – Natural Health Product / Dietary Supplement Company
Regulatory Audit Coordinator – Alberta Health Services
QA Manager – Oncothyreon, Inc. Formerly Biomira.

Contact info

John Simon

Areas of activity

  • Marijuana for Medical Purposes – MMPR
  • Marijuana Quality Assurance Pre-Licensing Report
  • Quality Assurance Reports for MMPR Licenses
  • MMPR Application Section 10
  • Quality Assurance Support for Division 4 and 5 of the Marijuana for Medical Purposes Regulations
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