Assurentry Team · February 2026
What Is ESG NextGen?
The FDA Electronic Submissions Gateway (ESG) NextGen is the updated platform for submitting electronic regulatory submissions to FDA. It supports drugs, biologics, devices, and other product types.
Key Changes from Legacy ESG
NextGen offers improved security, modern interface, and enhanced submission tracking. FDA is migrating users from the legacy ESG. Check FDA guidance for transition deadlines and compatibility with your submission types.
Submissions Through ESG NextGen
Common submission types include INDs, NDAs, BLAs, 510(k)s, PMAs, and facility registrations. Each has specific format and content requirements. Ensure submissions are eCTD-compliant where applicable.
Electronic submission support
Assurentry helps sponsors prepare and submit regulatory filings via ESG NextGen.
Get Submission HelpAccount Setup and Access
Register for ESG NextGen through FDA's portal. Obtain necessary credentials and configure submission roles. Test submissions may be available for validation before production use.
Best Practices
Validate submissions before sending, retain confirmations, and monitor submission status. Connect with your device registration and listing workflows for a complete compliance picture.
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Assurentry acts as a technical translation layer. You provide basic business info, and we automatically generate and file the exact electronic submissions required by the FDA.
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