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Submitting to ESG Gateway

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Written by Gayathri Aiyaswami

The 'Submit to ESG' feature enables users to submit submissions to FDA's ESG Gateway directly using the GS software with a smart technology that enables API Integration.

Below steps are followed to make use of this feature.

Step 1 - Set Up ESG Credentials

To submit to ESG, you must first configure your ESG credentials in the application using the browser-based Review platform.

  1. Log in to the browser-based Review platform.

  2. Search for and open the application you want to submit.

  3. In the top-right corner, click Actions and select ESG Credentials from the dropdown menu.

  4. In the dialog box that appears, enter your ESG Client ID and ESG Client Secret.

  5. Verify the details, then click Save.

  6. Once the credentials are saved, the following fields will be auto-populated based on the Client ID and Client Secret you entered:

    • ESG User ID

    • ESG Authorizing Company ID

    • ESG Company ID

Notes:

  • To configure ESG credentials, you must have the Submitter role in GS Security. This role is enabled by the Support team or a client space Admin.

  • You can retrieve your ESG credentials from the FDA's Unified Submission Portal (USP). See Tip 2 below for instructions.

  • If you have access to multiple client spaces (e.g., as a consultant), credentials must be set up once per space for submissions within that space.

Step 2 - Submit to ESG

  1. Within the application, click the sequence you want to submit from the eCTD tree.

  2. Click the Submit to ESG button.

  3. In the dialog box that appears, fill in the following fields:

    • Authorizing Company - Select from the dropdown (the default is your client space name).

    • FDA Center - Select the appropriate center from the dropdown.

    • Submission Mode - Use the toggle to select Test Submission or Product Submission.

    • Submission Type - Enter the submission type (eCTD or NeeS).

  4. Click Submit to complete the process.

  5. A green notification bar will appear in the right corner, confirming that the ESG submission has been queued successfully.

Step 3 - Verify Load Activity

  • Go to the Load platform and click the Activity tab.

  • The Activity window shows the progress of your submission from Step 2:

    • Compress - Indicates that the submission files are being packaged into a zip file for upload.

    • Submit to ESG - Confirms that the submission has been completed.

Step 4 - Review ESG Submission History

  1. Go to the browser-based Review platform.

  2. Click the ESG Submission History button.

  3. The dialog box will display the status of each submission, either Processing or Submitted to Center.

  4. Click any row to view full submission details, including submitter information and acknowledgements - similar to the confirmation emails received from the FDA.

Tips

1. On-Demand Webinar

For a walkthrough of the end-to-end process, watch the Certara on-demand webinar: Ready for ESG NextGen, or still submitting like it's 2015?

2. How to Retrieve ESG Credentials from the FDA Portal

ESG credentials are obtained from the FDA's Unified Submission Portal (USP) as below.

  • Visit the FDA page: Electronic Submissions Gateway Next Generation (ESG NextGen)

  • Click Industry USP Log In and complete the login process.

  • Once logged in, you will have access to the Unified Submission Portal (USP).

  • Navigate to the API Management section.

  • Click the blue + Generate button to create your Client ID and Client Secret.

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