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  • Home
  • Services
    • Compliance and Regulatory Affairs
      • FDA / Third-Party Audit Support
      • FDA 483, Warning Letters, Other Agency Citations
      • Liaison with Regulatory Agencies
      • Global Premarket Submissions
      • U.S. Agent
      • Adverse Event Reporting
      • Recalls and Safety Alerts
      • Ad/Promo Regulation
      • U.S. Import/Export
      • FDA Establishment Registration / Device Listings
    • Quality Management Systems (QMS)
      • Corrective & Preventive Action (CAPA)
      • Complaint Handling
      • Design Controls
      • Risk Management
      • GMP Training
      • Internal/Mock Audits
      • Management Responsibility
      • Production and Process Control
  • Testimonials
  • About Us
  • Blog
  • Contact Us