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About John Simon & Associates

Regulatory Affairs and Quality Assurance Consulting. The consultancy is active in the Medical Device, Pharmaceutical, Biotechnology, Cosmetic Ingredient and Natural Health Product (Dietary Supplement) industries. The principal consultant has a B.Sc. from the University of Alberta, is a Senior Member of the American Society for Quality, is a Certified Quality Auditor (CQA) through the American Society for Quality; has Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society; is a member of CAPRA and has RQAP-GLP certification through the Society of Quality Assurance. The company is actively involved in supporting/preparing companies for audits by the FDA, Health Canada and other jurisdictions in the areas of Medical Device Manufacturing, Drug Manufacturing and Testing, Drug and Device Establishments and Clinical Trial sites. The company also has experience with a number of submissions to Health Canada and the FDA.

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