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Address challenges, identify opportunities, and mitigate risk.

For over 20 years, small, medium and multi-national organizations have called upon us to provide GMP audit and quality support for regulated activities, improving quality control and quality assurance initiatives, and provide remediation guidance.

Services and Solutions

Our comprehensive services are designed to help improve your operational control, reduce costs, mitigate risks and ensure compliance with diverse regulatory demands.


  • Material Qualification
  • Method/Process Validation
  • Cleaning Validation
  • Computer System Validation
  • Facility Qualification

Documentation Services

  • Technical Writing
  • Standard Operating Procedures (SOPs)
  • Stability Program Design & Management
  • Quality Manuals & Policies
  • Finished Product Specifications
  • Work Instructions
  • Quality Agreements

Importation and Distribution Support

  • Importer QMS Program
  • Release / Reject Program
  • Importer Quality Assurance Person (QAP)
  • Distributor QMS Programs

Post Market Services

  • Post-Market QMS Programs
  • Recall Management
  • Ongoing Stability
  • Self Inspections
  • Vendor Qualifications

Audits and Remediation

A comprehensive GMP audit can identify GMP compliance and quality issues well before they become problems.  We provide a thorough evaluation of manufacturing operations, documentation processes, complaints handling and record keeping and provide recommendations for improvement.

  • Health Canada Inspection and NHP Inspection Program* (Virtual and Onsite Hosting & Support)
  • Health Canada NHP Inspection Program
  • The GMP Gap Analysis
  • Third Party Onsite Audits (Foreign & Domestic)
  • QAR
  • Remediation Plans

*Health Canada site license inspection pilot program


  • Good Manufacturing Practices (GMP) – Basics & Applied
  • Deviation, OOS Investigation and CAPA
  • Change Control
  • Pharmaceutical Process and Cleaning Validation
  • Stability (Shelf-life, On-Going, Accelerated and Freeze-Thaw)
  • Complaint Handling

Contact Us