Services to Ease FDA Regulatory Compliance

FAQ: Drug ESTABLISHMENT REGISTRATION

When do we need to renew Drug Establishment Registration?

Establishments must renew their registration annually, between October 1st and December 31st of each year.

How can Pragmatic help with Establishment Registration?

We prepare the establishment registration SPL on behalf of your company and submit to the FDA through our ESG gateway. We also provide US Agent services for non-US companies.

What are the fees for Establishment Registration?

The FDA does not charge any fee for Establishment Registration. See our pricing section for consulting fees.

How long will it take for Establishment Registration?

Generally, it takes two to three working days.

Does the FDA issue Certificates of Registration?

No. The FDA does not issue any certificates. You can verify your company registration at the below link: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

What information is required for Establishment Registration?

The contact address and DUNS number are required for Establishment Registration. Non US-companies are also required to provide US Agent information. If required, we can act as US agent for your company.

Who should register?

As per 21 CFR 207, domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.

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