John Simon & Associates Ltd.

Quality Assurance and Regulatory Affairs Consulting

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

Getting it done right the first time is not easy

but it is well worth the effort.

In your words

Testimonials

For Quality Assurance in a batch production, the person "to go" and "to learn from" is definitely John. Such detail oriented skill is essential for industries.

Imran Khan Research Assistant - Osteometabolix
John is a conscientious and thorough worker. He maintains a big picture view of the needs of the company and is able to implement quality improvement processes to ensure regulatory requirements are met. He is a pleasure to work with, has a great sense of humour, and is a fabulous team player. John is attuned to the needs of each team member and facilitates good communication and collaboration.

Sylvia Martin President, Smart ClinResearch Inc.