FDA ESG Compliant Digital Certificates from Comodo

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is a solution for accepting electronic regulatory submissions. The FDA ESG allows secure submission of regulatory information for review. It acts as the central transmission point for sending information electronically to the FDA.

The pharmaceutical industry needs to submit regulatory documents for review, and a secure digital environment is needed. The FDA ESG acts as a conduit to automatically route the documents to the proper FDA Center or Office.

Why do you need FDA ESG Digital Certificate

FDA has mandated that Digital Certificates must be used to encrypt documents in transmission. Comodo issues Digital Certificates that also help verify the integrity of the document received from a specified source.

A Comodo digital certificate is an electronic document which typically contains the owner's name and public key and other details about the certificate validity. The owner's name and a public key and a private key are bound together by the digital certificate, which can be used to encrypt and sign documents.

Encrypting the documents using certificates ensures that only the addressee (and no unauthorized users) can read the message. Digitally signing assures that the document has not been tampered with; authenticates the sender/source; and also prevents non-repudiation of origin and non-repudiation of receipt of the document.

The public key in the FDA's certificate is used to encrypt the document for transmission. The FDA ESG uses the public key to verify the digital signature of a document received from a specified source.

Comodo provides digital certificates with key lengths of 1024 or 2048 or 3072 as required by the ESG system.