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FAQ: Drug Establishment Registration
When do we need to renew Drug Establishment Registration?
How can FDAbasics 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. Our fee for drug establishment registration assistance is $ 299. Foreign companies have to pay a US Agent fee of $ 299.
How long will it take for Establishment Registration?
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