The race is on to find a cure for the Coronavirus disease (COVID-19), and with it, there are many questions we must ask. With the speed that this vaccine comes to market, will it be safe? How will the many worldwide companies working on a vaccine get their regulatory data submitted securely to their regulatory bodies like the US FDA “Federal Drug Administration” for review? Stacks of paper documents, disk drives or through secure file transfer?
The FDA alone receives an average of 500,000 secure electronic submissions each month. Their Electronic Submissions Gateway is the central transmission point for the receiving and sending of information electronically to the FDA.
Axway’s eSubmissions solution
How does the FDA acknowledge receipt, route to the proper FDA office and notify these offices of delivery? Using the Axway eSubmissions solution. For the companies that do not have a secure file transfer solution, don’t run to the mailroom just yet. Everyone has Internet access, so the FDA has deployed our Axway’s WebTrader Solution which allows companies to submit regulatory reports securely using a web browser. Not only does the FDA use the Axway eSubmissions solution to send and receive data, this solution has a global impact and is also used by these agencies.
Not just utilized by major government agencies as eSubmissions is the leader in the Pharmaceutical regulatory submission space. Axway’s eSubmissions solution allows Pharmaceutical Manufacturers and Contract Research Organizations (CROs) to provide reporting to agencies for New Drug Applications, Adverse Event Reporting and other required reports. It’s used to quickly and efficiently create collaborative connections that improve the efficiency of transmitting these reports which can range north of 8 GB in file size.
The platform-independent solution uses adaptive agents and a highly scalable, robust server to track securely and locate each regulatory submission through its communication gateways, translators and back-end systems—in real-time.
Axway eSubmission solution is a key component to help government agencies and Pharma customers receive regulatory approval for new drugs or vaccines to combat this epidemic.
Read how Axway implemented the Verification Router Service (VRS) solution to help pharmaceutical companies comply with FDA regulations.