FDA Drug Establishment Registration and Listing Fees
Transparent, competitive fees for all FDA registration, compliance, and U.S. Agent services. No hidden charges. Price-locked since 2009.
Price-Lock Since 2009
No Hidden Fees
150+ Countries Served
Since 2009
Drug Establishment
21 CFR Part 207 — Annual Registration Required
| FDA Registration, NDC Labeler Code & U.S. Agent Service | USD 649 / Year · No govt fee | |
| Drug Listing | USD 399 / Drug · No govt fee | |
| Drug Label Review | USD 649 / Drug | |
| DMF Submission & U.S. Agent Service | USD 649 / Year · No govt fee | |
| Drug Amount Reporting (CARES Act) | Contact Us | |
About Government Fees: The fees listed above are LMG professional service fees only. Some services include separate government fees charged directly by FDA — for example, the MDUFA device registration fee (FY2027: $13,785) and the export certificate filing fee ($175). These are paid to the U.S. government and are not retained by LMG. Government fees are noted above where applicable. All LMG fees are unchanged since 2009.
Ready to Get Started?
Select the service you need and get started today. Our specialists handle the entire process — no regulatory experience required on your end.
Contact Us Fee Estimator Tool