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Streamlined and Convenient Approach to Service Acquisition.
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)
Cosmetics Adverse Event Reporting Service
Cosmetics Responsible Contact Person Service
Cosmetics Product Listing
Cosmetics Facility Registration
Cosmetics Facility Renewal
GMP (QMS) Compliance Preparation
Drug Establishment Registration Service
Drug Establishment Renewal Service
Product Listing (NDC #)
US Agent Service (only for foreign companies)
Issue of Reactivate Labeler Code
OMUFA User Fee