Extensive Industry Experience.

Proven Regulatory Strategies.

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Regulatory Affairs

QA/RA Consulting Group offers extensive industry experience regarding:

  • Regulatory Strategies (Devices / Drugs / Biologics)

  • Global Medical Device Approval and Registration (ROW)

  • Experts in HIPAA / HITRUST / GDPR / ISO27001

  • FDA Warning Letter / 483 Support

  • PMA Submissions / 510(k) Notifications

  • Device Registration and Listing

  • FDA Consent Decree Support

  • CE Marking / European MDR Compliance

  • Tech Files / Design Dossiers

  • Health Canada CMDR Compliance and Licensing

  • Complaint Management / Adverse Event Reporting

  • U.S. Designated Agent for Foreign Manufacturers

  • Post Launch Regulatory Support

  • Master File Preparation and Maintenance

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