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SHOP  YOUR  VISION

Streamlined and Convenient Approach to Service Acquisition.

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MEDICAL DEVICE

  • FDA Compliance Label Review Service

  • FDA US Agent Service

  • Certificate to Foreign Government

  • Official Correspondent and Regulatory Contact Service

  • FDA GUDID Compliance

  • FDA Annual Establishment Registration User Fee (FY 2024)

  • FDA GUDID Compliance Device Listing

  • QMS

  • Device Listing

  • 510(k)

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COSMETIC

  • FDA Compliance Label Review Service

  • Cosmetics Adverse Event Reporting Service

  • Cosmetics Responsible Contact Person Service

  • Cosmetics Product Listing

  • Cosmetics Facility Registration

  • Cosmetics Facility Renewal

  • GMP (QMS) Compliance Preparation

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OTC DRUG

  • Drug Establishment Registration Service

  • Drug Establishment Renewal Service

  • Product Listing (NDC #)

  • FDA Compliance Label Review Service

  • US Agent Service (only for foreign companies)

  • Issue of Reactivate Labeler Code

  • OMUFA User Fee 

  • GMP (QMS) Compliance Preparation

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