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FDA Compliant Digital Certificates
Get your Digital Certificate for the
ESG from GlobalSign.
Due to FDA regulation changes, Digital Certificates are required for submitting electronic documentation to the FDA. GlobalSign is an approved provider of digital certificates for the FDA Electronic Submissions Gateway (ESG).
Digital certificates are used to authenticate digital information by using cryptographic technology delivered through a Digital Certificate. GlobalSign's PersonalSign Digital Certificates (PersonalSign 2 Pro & PersonalSign 1) are compliant X.509 version 3 Certificate for use with the FDA ESG.
PersonalSign 1
A non identity assurance certificate for individual identitites wishing to secure email, sign Microsoft Office documents and submit documents electronically to the FDA ESG.
PersonalSign 2 Pro
A high level multi-use certificate for
identities representing organizations wishing to secure email,
sign Microsoft Office documents and submit documents electronically to the FDA ESG.
PersonalSign 1 - Class 1 Digital Certificate
PersonalSign1 is a class 1 X.509 version 3 certificate with validity peroid up to 3 years that binds the identity of an individual subscriber to a validated email address.
(e.g john.doe@abccompany.com)
*The FDA recommends purchasing a digital certificate with 3 years validity.
PersonalSign2 Pro - Class 2 Digital Certificate
PersonalSign 2 Pro is a class 2 X.509 version 3 certificate with a validity peroid up to 3 years that combines the indentity of an individual with that of a vetted organization and is suitable for making electronic submissions on the behalf of a company (e.g. John Doe at ABC Company).
*The FDA recommends purchasing a digital certificate with 3 years validity.
Digital Signatures help to establish the following assurances with the FDA
- Authenticity – the digital signature helps to assure that the document author is who he or she claims to be
- Integrity – the digital signature helps to assure that the content of the document has not been changed or tampered with since it was digitally signed
- Non-repudiation – the digital signature helps to prove to all parties the orgin of the signed content. "Repudiation" refers to the act of a signer denying any association with the signed content.
Electronic Submissions Supported by the FDA ESG
- AERS – Adverse Event Reports
- AERS Attachments
- BLA – Biologics License Application (eCTD and eBLA format)
- eCTD – Electronic Common Technical Document
- H1N1 Lot Release
- IDE – Investigational Device Exemption
- IND – Investigational New Drug Application (eCTD and eIND format)
- DMF – Drug Master File
- Promotional Materials
- Lot Distribution Data
- ANDA – Abbreviated New Drug Application
- NDA – New Drug Application (eCTD and eNDA format)
- Adverse Events
- Electronic Submissions
For more information about the FDA ESG, please visit the FDA Website.
*A PersonalSign Digital Certificate is a compliant digital ID for the FDA ESG, the use of the FDA logo is
for informational purposes only in relationship to our products. We are not making any
representation for the said agency. The FDA does not suggest nor endorse any private
organization, product, or service.
