Get complete assistancr for GDUFA self identification and FEI number for your firm.
GDUFA SELF IDENTIFICATION
The Generic Drug User Fee Amendments – or GDUFA – is the mandatory process that requires drug facilities, sites and organizations related to a generic drug submission to provide information about their identity. Self-identification must take place annually, between May and June.
FDAbasics LLC offers a complete solution to GDUFA self-identification, including assistance with FEI and DUNS numbers, and technical support on SPL or XML conversion. We will guide you through all parts of the process, and stay with you until you have completed self identification.
We offer a fixed price of $299 for this consultancy service, with discounts available for small companies and multiple submissions.
Why choose FDAbasics for GDUFA Self Identification?
- PWe provide complete assistance for the FDA self-identification process
- PWe offer the lowest fees and do not increase them for annual self-identification
- POur services are transparent, with no hidden charges
- PWe will guide you to identify the correct business operation for your facilityIncorrect information in the GDUFA self identification make your facility liable for the FDA fee
- PWe offer discounts for multiple facility self identification and small business.
- PWe assure client confidentiality
To start your self-identification process, simply complete the online form and we’ll get back to you with any questions.
Completion of the process is usually within four working days.