Axway eSubmissions. Fast. Secure. Integrated with Oracle Argus.
Accelerate submissions of events, applications, and critical data worldwide with a simple, secure, and globally compliant process.
Electronic submissions management for pharmaceutical companies and CROs
Axway eSubmissions capabilities
Keep pace with regulators
When regulators change requirements, you need to keep up. Axway eSubmissions supports multiple protocols to ensure your connections are secure and that you consistently comply with regulatory authorities.
Manage movement to the cloud
Moving to the cloud? Axway eSubmissions allows you to deploy wherever you want. It provides secure, reliable access and control for your safety processes when you’re moving to the cloud.
Speed and simplify submissions
The next-gen eSubmissions gateway streamlines the process of preparing, making, and managing electronic submissions. Instantly locate and track your submissions across gateways, translators, and back-end systems.
Take a standardized approach
If you’re a Contract Research Organization (CRO) working with multiple pharma companies, you can create standardized practices for the eSubmissions process that apply across all of them.
Handle all protocol types in one process
Move beyond the typical limits of one-to-one relationships between protocols and instances of your safety database. eSubmissions gateway lets you manage all the protocols necessary to communicate locally and globally.
Talk to the FDA your way
Engage with the FDA in the way that’s easiest for you. With Axway eSubmissions, you can submit via the traditional eSubmissions, AS2, and/or API–whichever makes the most sense.
Frequently asked questions
What is Axway eSubmissions?
Axway eSubmissions is a specialized solution that enables pharmaceutical companies and CROs to securely transmit regulatory data, applications, and reports to health authorities such as the FDA and other global agencies.
It acts as a central submission gateway, ensuring secure, compliant, and reliable data exchange across regulatory ecosystems.
When should I use Axway eSubmissions?
Axway eSubmissions is essential when organizations need to submit regulatory data to health authorities, such as new drug applications, adverse event reports, and clinical or safety data.
It is particularly relevant for organizations handling high volumes of submissions, large payloads, or multiple regulatory endpoints, where reliability, performance, and traceability are critical.
What makes Axway eSubmissions different from other solutions?
Axway eSubmissions stands out as a regulatory connectivity gateway, not just a submission tool.
It supports multiple submission methods, including FDA ESG-based submissions, AS2, and APIs, within a single workflow, providing flexibility to interact with regulators using the most appropriate channel. It also delivers end-to-end visibility across gateways, translators, and backend systems, and is designed to handle large and complex submissions at scale.
With built-in support for evolving models such as API-based FDA submissions, it ensures organizations stay aligned with regulatory changes while maintaining performance and reliability.
What capabilities does Axway eSubmissions provide?
Axway eSubmissions enables organizations to prepare, send, and track regulatory submissions through a unified and secure process.
It provides multi-protocol communication, real-time visibility across submission flows, support for large file and high-volume data exchanges, and integration with enterprise and safety systems such as Oracle Argus.
This ensures efficient, reliable, and fully traceable submission management.
How does Axway eSubmissions ensure compliance and future readiness?
Axway eSubmissions is built to align with FDA and global regulatory requirements, ensuring secure and compliant data exchange.
It supports evolving regulatory interfaces, including the transition toward API-based submission models, and provides the scalability and reliability required for mission-critical submissions.
This enables organizations to remain compliant while preparing for the next generation of regulatory communication.