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FDA ESG Digital Certificates

X.509 Certificates for use with
the FDA ESG & Secure Email

FDA ESG Compliant Digital Certificates from GlobalSign

Digital Certificates are now required for submitting electronic documentation to the FDA Electronic Submissions Gateway as well as communicating securely with the the FDA over email.

Digital Certificates for use with the FDA ESG  are used to encrypt documents in transmission and the FDA ESG uses the Digital Certificate to verify the integrity of the document received from a specified source. The same digital certificate can be utilized to send secure encrypted email messages to the FDA and other external recipients.

PersonalSign 1 PersonalSign 2 Pro
Digital Certificate Binds to: Email address only
(joe.smith@abc.com)
Email address, individual identity & company identity (Joe Smith, ABC Company, joe.smith@abc.com)
Meets ESG Requirements
Meets Secure Email Requirements
Support: No Support
Online knowledge Base Only
Email, phone, online & live chat
Pricing
Pricing 1 year: - -
Pricing 2 year: N/A -
Pricing 3 year: - -

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The minimum requirement for a Digital Certificate for use with the FDA Electronic Submissions Gateway is a Personal Identification Certificate which GlobalSign brands as PersonalSign1 Certificate. GlobalSign also offers a high level security (PersonalSign2Pro) that binds to the individual's name, company name and email.

Steps to Preparing your Certificate for the FDA ESG

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  • 1

    Order your Certificate

  • 2

    Install your Certificate

  • 3

    Export your Private and Public Keys

  • 4

    Send Test Submission using Public Key

  • 5

    Begin Sending Submissions to FDA ESG

For more information on these steps, please refer to our FDA ESG knowledge-base.

Steps for Preparing Certificate to Exchange Secure Email with FDA

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  • 1

    Order your Certificate

  • 2

    Install your Certificate

  • 3

    Configure your email client

For detailed instructions, please refer to Secure Email FDA support article

Ordering Multiple Certificates?

Save time - order all certificates under one account.

1. Place first/initial order via the GlobalSign website.
2. An account will be created on your behalf and your account credentials will be emailed to you.
3. Once you've received your account credentials, login to your account using your username (PARxxxxx) and click on the 3rd tab labeled "PersonalSign" and order additional certificates from the left hand menu under "New Certificate".