Creating an ESG Account: Tips for Success

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The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. It is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach the proper FDA Center or Office. Creating an ESG account requires many steps. Following are helpful tips for the successful creation of your ESG account.

Two methods for making submissions to FDA

Webtrader

WebTrader is a web-based interface used to send documents and receive receipts and acknowledgments from the FDA. The WebTrader application makes communication with the FDA simple, cost-effective, and time-independent.  WebTrader requires each user from an Industry Partner to register for their own unique WebTrader account. Follow these instructions to request your Webtrader account.

AS2 (System-to-System)

Industry Partners have the option to access the Gateway via system-to-system communication. System-to-system communication (often referred to as an AS2 Account) provides an automated connection to the FDA for submissions, receipts and acknowledgments. The system-to-system communication requires server(s) and software procurement and configuration from Industry Partners. System-to-system communication requires one user from an organization to register for the organizational account. Submissions can be sent automatically or manually and receipts and acknowledgments may be received asynchronously or synchronously.

For the purpose of this post, we will be using the WebTrader method to create an ESG account.

Creating an ESG Account Using the Webtrader Method

Several steps are required in order to create an ESG Account, including:

  1. Requesting a Webtrader test account through the ESG Help Desk
  2. Obtaining a personal digital certificate
  3. Registering your test account
  4. Setting up your PC for ESG
  5. Sending test submission(s)

More details and specific instructions, as well as a helpful checklist, are provided by the FDA here.

Tips for Success

Navigating through all these instructions can be tricky. Following are some tips for success:

1. Follow the FDA’s checklist and instructions carefully.

2. Choose GlobalSign

Choosing GlobalSign to obtain a personal digital certificate is a great option. GlobalSign offers excellent step by step instructions with screenshots. These steps cover all you need to know from purchasing your certificate to getting your ESG account approved by the FDA. Their customer support provides great service and quick responses, as well.

3. Communicate clearly and promptly

Instructions require you to correspond with the ESG Help Desk between steps. Keep in mind you may be corresponding with different people each time. With that being said, we find it helpful to respond promptly during correspondence. Be as detailed, clear, and thorough as possible in your emails to the ESG Helpdesk; this helps move things along more efficiently.

4. Save your passwords

Throughout the process of creating an ESG account, you will need to create two passwords: one for your personal digital certificate, and one for accessing WebTrader. Be sure to store all your passwords in a secure place so that you can refer to them with ease and avoid complications.

5. Use the Help Desk

Remember, you can always contact ESGHelpDesk@fda.hhs.gov regarding any questions or concerns you may come across during the process.

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Author: Shenell Bailey

Shenell Bailey has worked for Synchrogenix for nearly four years as Senior Regulatory Submission Specialist.

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