FDA Awards Electronic Submissions Gateway Contract to GlobalNet Services

The U.S. Food and Drug Administration (FDA) has awarded a task order worth $32.2 Million to GlobalNet Services, Inc. (GNSI) to provide support for the Electronic Submissions Gateway (ESG) for the next five years.  The task order, issued under the Enterprise Lifecycle Management Systems (ELMS) vehicle, will include System Life Cycle Management support and services including planning, design, development, testing, implementation, and operations and maintenance of the ESG. GNSI has supported the ESG since its inception in 2005.

The ESG is the central receipt point for submitting electronic information to the FDA, routing it to its appropriate destination within the Agency.  ESG is comprised of Axway, Inc.’s Synchrony Gateway^®, Interchange^®, Activator^®, and Synchrony Sentinel^®, which enables the secure exchange, routing, and delivery monitoring of documents between the FDA Transaction Partners and the FDA. The infrastructure of the ESG is designed to allow multi‐gigabyte transfer of documents across the processing chain, i.e., from the servers receiving the submissions to the FDA Center Systems viewing the documents and vice versa. It is composed of industry‐standard commercial off-the-shelf (COTS) products configured to provide high throughput and availability with additional Java^® custom monitoring code applied and registered with Axway.

When the award was announced, Dr. Dan Goldman, Executive Vice President and Chief Science Officer at GNSI, commented, “The capability to securely transmit New Drug Applications and Adverse Event Reports electronically to FDA through the Electronic Submissions Gateway provides a huge return on investment for both FDA and industry.  GNSI thanks FDA for their confidence in us and we look forward to supporting and enhancing ESG for the next five years.”