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Quality System

We believe that learning and improvement are continuous endeavours both in scientific advancement and in Quality Compliance. We stay up to date and ahead of the curve on compliance through a mix of ongoing training and education, internal controls and audits, periodic review, risk identification and management, timely communication and continuous process improvement. Our quality management system is aligned with current regulatory requirements:

  • Health Canada Good Manufacturing Practices Guidelines (GMP)
  • US FDA current Good Manufacturing Practice (21CFR Part 210, 211 and Part 11)
  • Health Canada GLP Regulation (based on OECD GLP Principles)
  • Good Laboratory Practices (21CFR Part 58)
  • European Medicines Agency (EMA)
  • International Conference on Harmonization (ICH)
  • ISO 17025 Regulations for Testing Laboratories

Regulatory Support

We understand that time is a critical component to our customer’s business, especially when it comes to filings and approvals. That’s why we provide comprehensive data packages and technical guidance to our customers in support of their regulatory submissions, which enables faster filing and approvals. We are experienced in working with regulators and addressing their inquiries, with a proven record of successful FDA and Health Canada inspections.