Case Study: PhACT Corporation achieves secure, compliant eCTD submissions to the EMA with ArcESB AS2 Connector

PhACT Creates & Submits Marketing Authorization Applications for Drug Approvals

PhACT Corporation, a Swiss drug regulatory affairs consultancy that creates and submits eCTD-format marketing authorization applications, needed a Drummond-certified AS2 solution to meet the European Medicines Agency’s eSUB gateway requirements. Seeking a customizable, easy-to-implement and cost-effective AS2 option, PhACT turned to ArcESB and its ArcESB AS2 Connector after finding other solutions prohibitively expensive.

ArcESB delivered the Drummond-certified ArcESB AS2 Connector, a service-enabled, cross-platform AS2 solution with advanced restart and firewall features that integrates with existing systems and supports remote access. Using ArcESB, PhACT securely created and transmitted eCTD submissions to the EMA, achieved full implementation in under two months, and gained compliant, reliable transmissions while avoiding the high costs of competing products.

PhACT Corporation

Barbara Jentges

Chief Executive Officer