CASE STUDY

PhACT Corporation

RSSBus Connect help PhACT create and submit marketing authorization applications for drug approvals.





PhACT approached RSSBus with a crucial need to their consultancy service: create and submit marketing authorization applications for drug approvals via a Drummond Certified AS2 solution.

A Swiss-based Drug Regulatory Affairs consultancy services company, PhACT focuses on creating and submitting electronic submissions in eCTD-format for marketing authorization application for medicinal drug products. PhACT required AS2 messaging because their organization needed to meet submission requirements of the eSUB gateway used by the European Medicines Agency (EMA).

PhACT needed a tried-and-true AS2 solution for creating and submitting electronic submissions in an XML-based format. With customers in the pharmaceutical industry located across the globe and specific gateway requirements, PhACT needed a solution that was customizable, easy to implement and cost-effective.

"Everywhere we turned we saw exorbitant prices for AS2 solutions," Barbara Jentges, PhACT CEO, said. "We were almost at the point of way over paying for an inferior product, when I came across the RSSBus AS2 Connector."

The RSSBus AS2 Connector is a Drummond-certified, eBusinessReady™ application for sending and receiving files between trading partners through AS2, the leading standard for secure Internet EDI communications. With a full range of features including cross-platform support, integrated 'AS2 restart', and advanced firewall options, the AS2 Connector includes messaging features unavailable in solutions costing ten times as much. Thousands of users of the AS2 Connector have utilized the extreme flexibility in integration with other systems, applications, and platforms through the unique Service-Enabled™ features of the RSSBus AppServer framework

"The solution works perfectly! It is a great relief to know that I don't need to worry about whether my EMA submissions are being properly and securely handled. Not only is this a great product, but the support is fantastic." — Barbara Jentges, CEO, PhACT Corporation

PhACT used the AS2 Connector to securely create and send eCTD-formatted submissions to the European Medicines agency through the electronic submission gateway required by the drug approval agency. Since the connector is service enabled, PhACT was able to access the solution from any remote location, seamlessly integrate it within their organization, and customize the application to fit their industry-specific needs.

With the RSSBus AS2 Connector at their disposal, PhACT was able to rapidly implement the secure AS2 solution. From the initial planning stages to implementation, the entire project was up-and-running in less than two months.

"The solution works perfectly! It is a great relief to know that I don't need to worry about whether my EMA submissions are being properly and securely handled. Not only is this a great product, but the support is fantastic. They were fast in reaction time and professional in outcome," Jentges said.







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RSSBus (www.rssbus.com) is a leading provider of data access and connectivity solutions, specializing in the development of data integration technologies for realtime access to online or on-premise applications, databases and web APIs.

Our flagship product, RSSBus Connect, is used by more than 100,000 customers worldwide and is the only Drummond Certified AS2/AS4 solution that is completely free for use with a single trading partner.


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