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Enterprise PKI (ePKI) for use of the FDA Electronic Submissions Gateway (ESG)

Digitally Sign documents for the FDA ESG with a GlobalSign Digital ID for the highest levels of trust.

Due to FDA regulation changes, Digital IDs (digital certificates) are required for submitting electronic documentation to the FDA. GlobalSign is an approved provider of Digital IDs for the FDA Electronic Submissions Gateway (ESG).

 

Digital IDs are used to authenticate information by using cryptographic technology delivered through the Certificate file. A PersonalSign 2 Pro is the approved digital ID (digital certificate) for the FDA ESG and is available in packs starting from as few as 5 through ePKI. Alternatively, GlobalSign offers individual PersonalSign 2 Pro Digital IDs for the FDA ESG.

  • Cost Effective – simply purchase packs starting from only £295 for 5 Digital IDs*
  • Perfectly suited for the small to medium Enterprise or large organisations wishing to pilot or start with smaller roll-outs
  • Carries no set-up fees and no annual hosting fees - pay only for the Digital IDs issued
  • Includes additional 10% of initial purchase in form of free Digital IDs for user attrition and/or support considerations
* Price for 5 pack of PersonalSign for individuals Digital ID type. Other Digital ID types vary in price, contact us for custom quotes of 5+ or click on Buy Now for more details for pricing for all Digital ID types.

Secure Email & Document Signing for digitally signing FDA ESG documents

PersonalSign 2 Pro Digitals IDs available through ePKI allow users to secure email and produce instantly validated Microsoft Office Suite Documents (Word, Excel, PowerPoint) by adding digital signatures to the file. Once signed, the document carries cryptographically verifiable information on the author of the document and ensures the recipient can verify the document has not been tampered with.

Learn more about ePKI for your specific business need:

Secure Email Adobe PDF Document Signing Microsoft Office Document Signing Online Authentication

Secure Email

Adobe PDF Document Signing

MS Office Document Signing

Online Authentication



  • Inclusive Features
    • Immediate issuance of Digital IDs across the enterprise or across multiple departments, including free setup for multiple business unit/department profiles
    • Administrator initiated user registration for known applicants & Public Ordering Page for "open enrolment"
    • LDIF (LDAP Data Interchange Format) for Digital ID file export to directories
    • Transparent trust from the widely distributed trusted GlobalSign Root Certificate in all Windows, Apple & Adobe applications - view full compatibility
    • Shared issuing Certificate Authority for easy and fast set-up
    • Full reporting for easy planning and status checking of organisation-wide requests
    • Email template customisation allowing tailored message to your end users
    • Integration into the GlobalSign Certificate Center (GCC) web portal allowing for one-stop Certificate shopping (full access to SSL & Code Signing Certificates)


    Receive immediate discounts over multiple retail purchases and gain a faster ROI than using a competing platform. There are no hidden costs and you only pay for the Certificates you issue. Contact us to get a Custom Quote.

  • Example Organisation setup with ePKI
    Managed multiple Digital IDs with Enteprise PKI
  • 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
    • AERS – Adverse Event Reports
    • AERS Attachments
    • ANDA – Abbreviated New Drug Application
    • BLA – Biologics License Application (eCTD and eBLA format)
    • eCTD – Electronic Common Technical Document (includes DMF - Drug Master File)
    • NDA – New Drug Application (eCTD and eNDA format)
    • IND – Investigational New Drug Application
    • Adverse Events
    • Electronic Submissions
  • Why Choose GlobalSign?
    • Some of the biggest global brands and many Governments choose GlobalSign

    • We’re easy to do business with. We answer the phone. We listen to you and support your needs

    • We operate multi-lingual Technical Support offices around the world

    • We offer optional 24/7/365 Premier Support levels

    • We have been WebTrust for Certification Authorities compliant since 2002 and operating a trusted PKI network for since 1996

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