Precise Software Solutions Inc. (Precise) is proud to announce it has been awarded a new contract from the U.S. Food and Drug Administration (FDA) to support the Electronic Submission Gateway (ESG) Next Generation (NextGen) program.
The ESG NextGen system will replace the legacy ESG platform. It will provide for receiving, packaging, transmitting, and routing electronic regulatory submissions across FDA centers. This solution enhances submission capabilities, improves business processes, and delivers a secure user experience. The modernization includes a transition to a cloud-based environment, development of a Unified Submission Portal, and incorporation of feedback from industry through pilot testing.
Under this contract, Precise will provide technical and management services required to support ESG NextGen. These include project management, transition planning, systems integration and engineering, data migration and management, operations and maintenance, helpdesk support, and eventual system and data disposition.
“Precise is honored to continue to support the FDA’s mission to modernize its regulatory submission infrastructure,” said Zhensen Huang, CEO of Precise. “Our work on ESG NextGen will help ensure a more efficient, secure, and streamlined process for both the FDA and its stakeholders, contributing to faster regulatory decision-making and better public health outcomes.”
This award highlights Precise’s continued commitment to technological initiatives that empower federal agencies to leverage innovative solutions to support public health missions.
