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.
Pragmatic offers a completed 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. Remember, the FDA does not charge for self identification.
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.