Regulatory Compliance and Quality Assurance

Regulatory Compliance and Quality Assurance

From helping small start-ups navigate through regulations to partnering with major pharmaceutical firms for Greenfield projects, we make sure our clients meet regulatory requirements and quality standards while maintaining efficiency in their projects and everyday operations.

We serve the life sciences market by offering comprehensive expertise in Canadian, U.S. and international regulations and standards. Working with our clients, we make sure projects are fully compliant throughout the lifecycle, from design and construction through to testing and operations, and again during remediation and decommissioning. Our shared goal is to ensure project acceptance by all stakeholders, as well as regulatory agencies such as the U.S. Food and Drug Administration, Health Canada and the European Medicines Agency.

We’re flexible in how we deliver our expertise. Depending on client needs, we can offer scoped mandates or personnel loans. We can also provide an objective and informed expert opinion through consultations to assist clients with projects and operations.

More specifically, some of the services we offer include:

  • Specification and design review
  • Gap, impact, criticality and risk assessment
  • Compliance support during construction
  • Site directive/change control review
  • Protocol and test result review and approval
  • Validation periodic reviews
  • Procedure writing and review
  • Training and training support
  • Quality management
  • Regulatory affairs
  • Pre-audit services
  • Auditing
  • Remediation plan development
  • Preparation, review, approval and management of production, regulatory and quality processes and records
    • Batch records
    • Deviations
    • CAPAs
    • OOT/OOS
    • Change control
    • Recalls
    • Complaints
  • Project and program management
  • Interim department management

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