QnR Associates

Services Overview

7

Our Services

Our consulting services range from regulatory affairs and quality assurance services to product development and manufacturing process flow design, mapping and validation.

Compliance and Regulatory Services

Our consulting services range from regulatory affairs and quality assurance services to product development and manufacturing process flow design, mapping and validation.

A C M P R

  • Marijuana for Medical Purposes – ACMPR
  • Marijuana Quality Assurance Pre-Licensing Report
  • Quality Assurance Reports for ACMPR Licenses
  • ACMPR Application Section 10
  • Quality Assurance Support for Division 4 and 5 of the Marijuana for Medical Purposes Regulations
  • Quality Assurance Management services for a Biotechnology company.

Quality Assurance

  • 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.
  • Commercial Production batch record review.
  • Review and assessment of deviations, CAPA and Change Control.
  • SOP writing (Deviation Management, Change Control, Auditing)
  • Manufacturing Master Batch Record writing
  • Failure investigations of Manufacturing Facilities.
  • Vendor qualification audits.
  • For cause audits and associated CAPA review.
  • Technology Transfer.
  • New product development.
  • Investigational Testing Authorizations.

Regulatory Services

  • On-site support for the FDA PAI.
  • Clinical Trial protocol writing and review to assure compliance to ICH E6.
  • Clinical Trial Applications, CTA and IDE.
  • Technology Transfer.
  • Product License For Natural Health Product Applications.
  • Site License For Natural Health Product Applications.
  • Health Canada audit preparation and audits.
  • New product development.
  • Regulatory research and classification.
  • Pre-Meetings withthe FDA and Health Canada

Get in Touch

Should you wish to obtain more information about QnR Associates or enquire about our services please do not hesitate to contact us.

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