Confidence Beyond Compliance

Regulatory Maintenance Services:

  • Site registrations
  • Product listings
  • Export certificates
  • Import clearances
  • Product labeling reviews
  • Technical file and CER updates
  • Post-market surveillance reports
  • QA / RA due diligence for acquisitions
  • QMS integration across business
  • Regulatory intelligence
  • QMS procedural templates
  • US Agent / Official Correspondent
  • QA / Compliance & RA on-going advice
  • Interim staffing for RA / QA leadership positions
  • Post-market surveillance staffing: complaint handling unit, adverse event filings, recall mailing / tracking