eWAY-eCTD SOLUTIONS have been Providing the ESG gateway services for USFDA, Health Canada and Europe Markets

ESG-Overview

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG is a highly scalable, easily available, high performance and secure exchange point for FDA and its partners to transact a variety of documents and submissions over industry-standard protocols. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. The FDA ESG enables the FDA to process regulatory information automatically, functioning as a single point of entry for receiving and processing all electronic submissions in a highly secure environment.  The FDA ESG complies with secure Hypertext Transfer Protocol (HTTP) messaging standards and uses digital certificates for secure communication. The electronic submission process encompasses the receipt, acknowledgment of receipt (to the sender), routing and notification (to a receiving Center or Office) of the delivery of an electronic submission.

Method of Submission of ESG

FDA ESG provides two methods, WebTrader (WT) and AS2, for making submissions to FDA.  FDA ESG has been in production since 2006 and is used by 100s of users to send 1,000s of submissions every day.

• WT: A web portal designed for low volume submitters. WT allows users to login, digitally sign and submissions, and view responses through a simple web interface.

• AS2: A system-to-system connection to exchange submissions with FDA. AS2 requires a Gateway software implementation on submitters end.

Benefits of ESG

• Saves time

• Hassle-free and inexpensive mode of submitting documents

• Automatically directs the documents to the required FDA officer/center

• Provides notifications to the concerned officials of the FDA as well as acknowledges sender with receipts.