FDA ESG NextGen for Regulatory Submissions

There are many features that will ultimately simplify the process of completing the transmission of eCTD (electronic Common Technical Document) submission packages to the FDA. Here are a few of the key benefits that explain why the FDA is transitioning to ESG NextGen:

• Significant submission size limit increased from WebTrader’s 8GB to 1TB available in release one of ESGNG. Further increases to file size are planned for future releases. This will allow sponsors to submit applications with increased amounts of data and avoid the need to split applications into separate submissions.
• The digital signing certificate binds together the owner’s name and a pair of electronic keys (a public key and a private key) that can be used to sign documents. Ever have trouble obtaining a digital signing certificate? You’re not alone. With ESGNG, a digital signing certificate is no longer needed. In its place, the widely adopted e-Signature is used to sign submission packages.
• The file upload experience is enhanced with the use of a simple plug-in (FileCatalyst) that provides multi-thread capabilities to allow multiple submissions to be sent concurrently, showcasing an accelerated file upload performance and efficient user interface.
• ESGNG allows users to check the status of submission via the Unified Submission Portal (USP) and to view details provided on FDA acknowledgements. The user who submitted no longer needs to retrieve the corresponding FDA acknowledgements. Other users can also monitor the status of a submission and view the FDA receipt information.
• User Management Functions allow companies to assign roles to submitters, which define what actions can be performed.

Two essential roles are available for industry leaders.

• Power Users – users with this role can edit company info, approve/deny user requests within the company, and have full access to all submissions of the company.
• Submitter – users with this role are limited to creating submission packages; they can view only the submissions they created and request a role change.

ESG NextGen will simplify the process of registering new users, submitting and managing submission packages. As the industry continues to evolve, you can count on Certara’s team of regulatory operations industry leaders and experts to remain informed and adapt to new and exciting trends and provide cutting-edge technology like our GlobalSubmit eCTD submission software.