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Global Regulatory Affairs and Compliance LLC

Global Regulatory Affairs and Compliance LLCGlobal Regulatory Affairs and Compliance LLCGlobal Regulatory Affairs and Compliance LLC
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Global Regulatory Affairs and Compliance LLC

Global Regulatory Affairs and Compliance LLCGlobal Regulatory Affairs and Compliance LLCGlobal Regulatory Affairs and Compliance LLC

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FDA Facility Registration

FDA Registration

  • US and Non-US Food Facility Registration 
  • US and Non-US Dietary Supplement Facility Registration
  • Medical Device Registration and Listing
  • Drug Establishment Registration and Listing
  • Cosmetic Facility Registration

Imports

  • Import Alert Removal from Red List
  • Import Detention Assistance
  • FSVP Services
  • Regulatory Guidance for all FDA products

Foods, Dietary Supplements, & Cosmetics

  • Registration & US Agent Services
  • Labeling and Ingredient review
  • Warning Letter & 483 responses
  • HACCP & Food Safety Plans
  • GMP/GAP consultation
  • FDA Audit readiness and guidance

Pharmaceuticals and Medical Devices

  • Registration & Listing 
  • US Agent Services
  • Warning Letter & 483 responses 
  • FDA Audit readiness and guidance

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