PhACT Creates & Submits Marketing Authorization Applications for Drug Approvals

PhACT Creates & Submits Marketing Authorization Applications for Drug Approvals


PhACT approached CData Arc with a crucial need in regards to its consultancy service. PhACT needed to 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 its organization needed to meet the 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," said Barbara Jentges, PhACT CEO. "We were almost at the point of way over paying for an inferior product when I came across the CData Arc AS2 Connector."

The CData Arc 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 this extreme flexibility in integration with other systems, applications, and platforms through the unique Service-Enabled™ features of the CData Arc 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, PhACT Corporation CEO

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 the solution within its organization, and customize the application to fit PhACT's industry-specific needs.

With the CData Arc AS2 Connector at its 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.