GlobalNet Services, Inc. Awarded Maintenance Contract for the FDA Electronic Submissions Gateway (ESG)

GlobalNet Services, Inc. (GNSI) has been awarded the maintenance contract for the FDA Electronic Submissions Gateway (ESG) project. The Gateway centralizes the receipt of submissions from regulated industry and other government agencies into a single system. Please see http://www.fda.gov/esg

The FDA ESG delivers a unified framework that helps establish relationships with trading partners, enables electronic business transactions, and provides visibility into each step of the e-submissions process.

Past efforts to respond to regulatory requirements, such as the Food and Drug Administration Modernization Act (FDAMA) and the Prescription Drug User Fee Act (PDUFA), which mandates the use of electronic submission systems, have been FDA Center-specific, focusing on a limited number of submissions. Initially, the FDA E-Submissions Gateway will focus on PDUFA-related submissions. Ultimately, the goal of the FDA E-Submissions Gateway is to provide a single entry point for all document submissions, between all affected FDA Centers and the institutions they regulate or with which the FDA exchanges information.

"GlobalNet Services, Inc. is honored to have been awarded the follow-on, maintenance contract to the FDA Electronic Submissions Gateway project. The award is a reflection of our staff’s efforts and dedication in implementing the ESG," said Dr. Daniel Goldman, Vice President of GlobalNet Services, Inc. "The GNSI Team has delivered a single point of entry for the receipt and processing of all electronic submissions in a highly secure environment. The system automates current electronic submission processes such as acknowledging receipt of submissions. GNSI has a successful twelve-year track record working with the FDA and we are looking forward to supporting the FDA ESG."