FDA Services

1. FDA Quality System Management

2. FDA Authorized USA Agent for Foreign Manufacturers

3. FDA Device Classification

4. FDA Device listing

5. FDA Initial Establishment Registration

6. FDA Establishment annual registration

7. FDA CFG certificate (Certificate of Foreign Government)

8. FDA 801 Export certificate

9. FDA 802 Export certificate

10. FDA CBER export Certificate

11. FDA Import for Export compliance system (ACE)

12. FDA UDI (Unique Device Identification) Compliance

13. FDA 483 Inspection Observations Response

14. Preparing and reviewing documents for FDA Audits