Axway eSubmissions. Fast, secure, electronic submissions.
Axway eSubmissions speeds submissions for events, drug applications, and critical data to the FDA and other regulatory bodies with a single solution that keeps electronic submissions compliant, simple, and secure.
Axway eSubmissions capabilities
Keep pace with regulators
Axway eSubmissions supports multiple protocols to keep you securely connected to regulators around the world and compliant with evolving requirements. Integrate seamlessly with multiple regulators and submission processes, including the U.S. Food and Drug Administration’s new API-driven submissions system, the Japanese Ministry of Health, Labour and Welfare (MHLW), and the European Medicines Agency.
Speed and simplify submissions
The next-gen, eSubmissions interface streamlines the process of preparing, making, and managing electronic submissions. Instantly locate and track your submissions across gateways, translators, and back-end systems.
Handle submissions of all sizes
Move beyond the file transfer limits of outdated systems not designed to handle large and complex submissions. Achieve payload versatility with submissions of all sizes — from single small files to large directories containing multiple files.
Create collaborative connections
Leverage the underlying Axway B2B integration platform to exchange data securely with submissions stakeholders, within and beyond your organization. Consolidate electronic submissions with other B2B operations and choose the right deployment model for your business: on-prem, hybrid, in the cloud, or a fully managed service.
Unlock the benefits of containers
Downtime needed for system upgrades and maintenance can knock you off the track to regulatory approval. Containerized deployment lets you bulletproof your submissions processes with high availability, zero-downtime maintenance, and automated updates.
How can we help?
How can we help?
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