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)
  • FDA Warning Letter / 483 Support
  • PMA Submissions / 510(k) Notifications
  • Sterilization Tech File Support
  • Device Registration and Listing
  • FDA Consent Decree Support
  • CE Marking / European MDD Compliance
  • Tech Files / Design Dossiers
  • 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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