Services
Consulting Services
JOHN SIMON AND ASSOCIATES LTD.
John Simon is a Senior Member of the American Society for Quality and a Certified Quality Auditor through the Regulatory Affairs Professional Society, with extensive experience in Medical Device, Pharmaceutical, Biotechnology and Natural Health Product industries. Our consulting services range from regulatory affairs and quality assurance services to new product development and certification.
Consulting Services
Relentless, Dedicated, Trustworthy.
Experience Diversity
- Access to Cannabis for Medical Purposes Regulations – ACMPR
- Marijuana Quality Assurance Pre-Licensing Report
- Quality Assurance Reports for ACMPR Licenses
- MMPR Application Section 10
- Quality Assurance Support for Division 4 and 5 of the Access to Cannabis for Medical Purposes Regulations
- Quality Assurance Management services for a Biotechnology company.
- Involved with the validation series for the manufacturing of a fast track drug.
- Quality Assurance Consulting services provided to support process validation; consistency series manufacturing; and Pre Approval Inspection (PAI) preparation. Preparation activities for both FDA and European Union inspections.
- On-site support for the FDA PAI.
- Commercial Production batch record review.
- Review and assessment of deviations, CAPA and Change Control.
- Failure investigations of Manufacturing Facilities.
- SOP writing (Deviation Management, Change Control, Auditing)
- Vendor qualification audits.
- Clinical Trial protocol writing and review to assure compliance to ICH E6.
- Clinical Trial Applications, CTA and IDE.
- For cause audits and associated CAPA review.
- Technology Transfer.
- Product License Applications.
- Site License Applications.
- Health Canada audit preparation and audits.
- New product development.
- Regulatory research and classification.
- Investigational Testing Authorizations.
- Pre-Meetings withthe FDA and Health Canada