FDA Self-Identification of Generic Drug Facilities
GDUFA requires generic drug facilities to self-identify with the FDA annually. LMG will prepare and submit your SPL Self-Identification file on your behalf.
Description of Services & Cost
| Services | Fees | Number of Services | Total Fees |
|---|---|---|---|
| Self-Identification of Generic Drug FacilitySPL preparation & submission to FDA via ESG — Annual (GDUFA) | USD 649 | $0 | |
| Total | $0 | ||
Registrant
The registrant is the owner or operator of the generic drug facility. If the facility is at a different location from the registrant, a unique DUNS number is required for both.
Facility
Provide details for the actual generic drug manufacturing or processing facility. If the facility is at the same address as the registrant, you may enter the same information.
Contact Person
The contact person at the facility for FDA communications regarding this self-identification.
Division the Drug is Regulated By
Type of Operation *
Select all types of operations performed at this facility.
Agreement
We appreciate your decision to select Liberty Management Group Ltd. ("LMG") to prepare and submit your Self-Identification filing to the United States Food and Drug Administration ("FDA") as required under the Generic Drug User Fee Amendments of 2012 (GDUFA). This Agreement describes the scope of our relationship with your company. By submitting the requested information to LMG, your company agrees to be bound by the terms and conditions listed in this document.
1. Services Provided
Our services will be limited to preparing and submitting the Structured Product Labeling (SPL) file required for FDA Self-Identification under GDUFA. The services include preparation of the self-identification SPL and submission via the FDA Electronic Submissions Gateway (ESG). On all submissions, "Liberty Management Group Ltd." will be identified as the "Official Correspondent" for your company. You understand and agree that the information your company provides to LMG will be used for the purpose of completing a public filing with the United States Government.
2. Client Information
You agree and warrant that all information your company provides to LMG, including but not limited to facility name, DUNS number, registrant information, type of operations, and FDA registration numbers (collectively, "Client Information"), is correct and truthful to the best of your knowledge. You understand and acknowledge that LMG will rely upon the Client Information your company provides. You further agree and warrant that you will promptly inform LMG of any changes in the Client Information that are required to be updated with the FDA.
3. Annual Requirement
Self-Identification under GDUFA must be submitted annually between May 1 and June 1 of each year. It is the client's responsibility to ensure that LMG is instructed to renew the self-identification on time each year. Failure to self-identify may result in products manufactured at the facility being deemed misbranded under federal law.
4. Termination Notices
Either party may terminate the relationship at any time for any reason by providing five (5) days' prior written notice to the other party. In the event of termination of this Agreement by either party, LMG shall not be liable to your company for any reimbursement or damages on account of the loss of prospective or actual sales or profits of your company. In no event shall LMG's liability exceed the amount of the fees paid by your company to LMG in any given calendar year.
5. Limitations
LMG shall not be liable for any delay in performing its obligations under this Agreement if such delay is caused by circumstances beyond LMG's reasonable control.
6. Governing Law and Venue
This Agreement and the interpretation of its terms shall be governed and construed in accordance with the laws of the State of Illinois, U.S.A., without regard to its conflicts of laws rules. The parties consent to the sole and exclusive jurisdiction and venue of the Illinois courts in Will County, Illinois, U.S.A.
Submitter Information
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