US FDA Registration and Related Services

• Appoint US Agent
• Submit Application with drug Information ( We will provide the form on request)
• Apply for NDC Number
• Complete the Establishment Registration ( We will do on behalf of your company)
• Complete the Listing

More info>> read

• Appoint US Agent
• Submit Application with cosmetic information ( We will provide the form on request)
• Submit ingredients statement to FDA
• If required, complete a label with EUROPECERT team
• Complete the Voluntry Cosmetic Registration progreme ( We will do on behalf of your company)

Review / check / GAP analysis of the existing label provided by your company
Please note - This service does not include label designing.

Fees for Label Review is 749 Euros/ label

All non US Medical Device Importers must identify/ appont a U.S. FDA agent. This information is a part of FURLS data entry system as its official correspondent. The US FDA agent has no responsibility to report adverse events under the Medical Device Reporting regulation.

The responsibilities of the US FDA agent are limited and include:

• Assisting FDA in communications with the foreign establishment
• Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the US
• Assisting FDA in scheduling inspections of the foreign establishment
• If FDA is unable to contact the foreign establishment directly, FDA may provide information or documents to the US FDA agent

US FDA will not issue any certificate to any manufacturer / organization.
US Agent office will issue a Certificate from there office.

Important: The agent certificate is not a valid legal notice. It can only be used for data verification.