Drug Establishment registration – also referred to as drug firm annual registration or FDA registration – is a mandatory requirement for any manufacturer or company that processes or tests drugs, including finished dosage forms, bulk drugs and OTC products for commercial distribution purpose in United States. All drug establishments must be registered within 5 days of starting operations, and they must update their drug establishment registration between October to December each year.
Pragmatic offers a complete solution to support organizations through the Establishment registration and renewal processes. This includes: assistance with obtaining a DUNs number; obtaining the FEI number; and the preparation and submission of the Establishment Registration. We continue to support you until your registration status is approved on the FDA website.
There are no FDA charges for registration, so we can keep our fees low, at just $299. It takes four working days to complete establishment registration. We also offer discounts for multiple facility registration.
As with other elements of the drug registration process, the FDA does not issue certificates for a completed registration. You can verify your registration status on the FDA website. Certificates issued by consulting firms are not valid.