FDA ESG
Digital Certificate

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of regulatory information for review.
The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach their final destination. It does not open or review submissions; it automatically routes them to the proper FDA Center or Office.

FDA ESG Digital Certificate

The digital certificate has a high level of security, binding to the individual’s name and email address.

Meets ESG requirements
Support Email, help desk ticket
Validity 3 Years*
Price 120 €
*FDA recommends using certificates with 3 years availability

Request the certificate

Fill out the details that will appear in your digital certificate. Please, ensure that information is correct and accurate, as any discrepancy will cause delays in the certificate issuance process.


Message

By supplying my contact information, I authorize Intesi Group S.p.A to contact me in order to provide technical support, should that be necessary for the issuance of my digital certificate.

More information regarding FDA ESG portal

For more information regarding FDA ESG portal and how to use your digital certificate for electronic submissions, please visit the dedicated FDA webpages:

https://www.fda.gov/industry/about-esg/esg-appendix-c-digital-certificates#4

https://www.fda.gov/industry/electronic-submissions-gateway

https://www.fda.gov/industry/about-esg/esg-submission-process

Do you need technical support?

Our technical support team stands ready to assist you with all of your technical questions regarding installing and using digital certificates for FDA ESG. How can we help you?

Contact us