GlobalNet Services, Inc. -GNSI- and Cyclone Commerce, Inc. to Create Single Point of Entry for E-Submissions to the FDA.
GlobalNet Services, Inc. (GNSI), in partnership with Cyclone Commerce, announced that it has been awarded the FDA Electronic Submissions Gateway project. The Gateway will centralize the receipt of submissions from regulated industry and other government agencies into a single system.
For the FDA E-Submissions Gateway solution, GNSI will use Cyclone Commerce's most advanced B2B platform, Cyclone Interchange(TM), the powerful transaction visibility solution, Cyclone Director(TM), and Cyclone's extensive domain expertise. Cyclone's solutions provide a secure, scaleable network that serves as the foundation for internal or B2B collaboration. The gateway 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 FDA Electronic Submissions Gateway project," said Ori Reiss, President of GlobalNet Services, Inc. "The GNSI Team will deliver to the FDA a single point of entry for the receipt and processing of all electronic submissions in a highly secure environment. The system will automate current electronic submission processes such as acknowledging receipt of submissions. GNSI has a successful ten year track record working with the FDA and we are looking forward to working on this important project, which will improve the timelines and effectiveness of the drug approval process. We are likewise proud to be working with Cyclone Commerce, who is a leader in delivering Smarter B2B solutions to the pharmaceutical and health care industry, as well as other business sectors."
"Cyclone Commerce is privileged to be working with GNSI to enable the FDA to move toward a paperless submission environment," said Phil Myers, president & CEO of Cyclone Commerce. "The single FDA E-Submissions Gateway will benefit the healthcare industry, namely the safety, time, complexity, latency, and expense of drug safety and submission processes. A streamlined submissions process will greatly assist regulatory agencies in their ongoing efforts to protect the public and improve healthcare. Cyclone is pleased to bring years of industry leadership in healthcare B2B enablement to this initiative."
About GlobalNet Services, Inc. (GNSI)
GNSI is a leading digital solutions provider that helps organizations leverage technology in pursuit of their business goals. GNSI works with clients to define, develop, and implement the web-based applications, integrated systems, and creative media they need to achieve competitive advantage. Since 1995, GNSI has been helping clients like the National Institutes of Health, the U.S. Food and Drug Administration, McKesson BioServices Corporation and the EMMES Corporation increase revenue, reduce costs, enhance productivity, and improve customer service.
GNSI has over ten years of experience working with the FDA to develop innovative solutions. These include the FDA Unified Registration and Listing System (FURLS), which allows the quick and efficient processing of food facility registrations over the Internet; Science FIRST, an agency portal which promotes scientific collaboration. GNSI also provides support for the FDA's Internet and Intranet infrastructures. GNSI is based in Rockville, MD.
More Information: www.gnsi.com
About Cyclone Commerce, Inc.
Cyclone is the world's leading provider of Smarter B2B solutions in the healthcare industry. Cyclone's 2,000 customers are some of the most well recognized brands, including the top 10 pharmaceutical manufacturers and all of the top healthcare distributors. In the drug safety marketplace, Cyclone powers the e-submissions gateways for Europe (European Agency for the Evaluation of Medical Products), Japan (Ministry of Health, Labour and Welfare), and the United States (Food and Drug Administration).
Cyclone provides Smarter B2B solutions that help businesses manage business-to-business processes from the edge of their enterprises rather than relying solely upon back-end systems. Cyclone software allows businesses to act in real-time upon information "in flight" between customers, suppliers and other important partners by getting the information flowing between trading partners giving them visibility into key processes and allowing them to manage events as they occur. Cyclone makes it easy to extend existing internally focused applications, integration and business intelligence investments outside the four walls of an enterprise. Founded in 1996, Cyclone Commerce is headquartered in Scottsdale, Ariz.
More Information: www.cyclonecommerce.com