At Asphalion a smooth transition from legacy ESG system has been achieved ensuring our clients submission continue to be on-time and according to latest industry standards.
In alignment with the FDA strategy the FDA Electronic Submission Gateway (ESG) has been modernized by the development of ESG NextGen.
ESG NextGen represents a significant milestone, addressing technical limitations of the old legacy ESG system, improving user experience, and providing advanced capabilities to handle a significant influx of larger-sized submissions in the event of a public health emergency. In addition, ESG NextGen provides the FDA and industry companies with a robust system that can quickly adapt to meet evolving regulatory requirements and public health needs.
The main new features are detailed below:
- A Unified Submission Portal for managing accounts and submissions.
- Improved transparency with real-time tracking and reporting.
- Enhanced cybersecurity with multi-factor authentication and removing digital certificates by electronic signatures.
- Allowing direct systems connection via an Application Programming Interface (API) .
- Enabling large file submissions.
More information available on the official FDA site:
https://www.fda.gov/industry/electronic-submissions-gateway
If you need support with ESG NextGen or regulatory submissions, we´re here to help! Contact our team at [email protected]
