Getting it done right the first time is not easy
But it is well worth the effort.
Regulatory Affairs
Auditing and assessing compliance with USA and Canadian regulations against GMP, GCP, and GLP
Product Development
Support of new product development including regulatory opinion research
Health Canada and FDA
Compliance work ISO 13485 Certification and FDA Code of Federal Regulations
- READY Always have a plan – it is the single most important first step to success.
- SET When your plan is set – surround yourself with the right people to keep you focused and on course.
- GO! A successful project is an equal measure of a great plan and smart work driven by focused determination.
John Simon Biography
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.
Senior Member – ASQ
Regulatory Affairs Certification – RAC
Registered Quality Assurance Professionals in Good Laboratory Practice – RQAP-GLP
John Simon and Associates Ltd.
Irreplaceable Experience