3 steps to fast, secure electronic submissions to the FDA and other global regulators

Axway eSubmissions speeds and simplifies electronic submissions of all sizes

The U.S. Food and Drug Administration (FDA) is rolling out a modernized and more secure API interface for handling the 500,000+ electronic submissions it receives each month for approval of new drugs, vaccines, and medical devices. Axway eSubmissions gives you out-of-the-box integration with this new system, letting you modernize and automate your submission processes in 3 ways.

01 Put a new face on submissions

It's only a matter of time before the FDA abandons the current AS2 submission interface in favor of its new, more modern API-based approach, making Axway eSubmissions the only automated solution available. Our next-gen API submissions interface keeps you in sync with the FDA and other regulators, now and in the future, while improving your ability to submit and track large files. 

02 Achieve payload versatility

Electronic EDA submissions range in size and complexity, testing the limits of file transfer processes not modernized to accomodate them. Designed for sending large messages, Axway eSubmissions securely transmits files of all sizes, from a single small file to a very large directory containing many subdirectories and files. 

03 Unlock the benefits of containerized architecture

Downtime needed for system upgrades and maintenance can knock your organization off the track to FDA approval. The containerized deployment architecture on Axway B2Bi Enterprise Edition lets you run Axway eSubmissions with high availablity, zero downtime maintenance, deployment automation, and the confidence that systems will stay up and running.

Ready to modernize your eSubmissions processes for versatility, speed, and security?

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