October 11, 2016

FDA Awards TCG Contract to Assess the Electronic Submissions Gateway

WASHINGTON, Oct. 11, 2016: The U.S. Food and Drug Administration (FDA) has awarded TCG, Inc. a contract to assess the key management and IT capabilities needed to define the next generation of its Electronic Submissions Gateway (ESG).

The ESG is the single point of entry for all electronic regulatory submissions such as post-marketing safety reports, pre-market regulatory submissions, and investigational submissions. It is estimated that by 2020 the system will receive 20–30 million submissions annually, including adverse event reports, new drug applications, biologics license applications, and investigational device exemptions. TCG, with subcontractor HeiTech Services, Inc., will conduct an independent analysis of alternatives by:

  • assessing current processes, requirements and technologies,
  • identifying modernization alternatives, and,
  • developing a phased-transition roadmap for implementation.

The ESG Analysis-of-Alternatives (AoA) contract is part of a larger effort among Federal agencies to modernize their existing IT systems. The task was awarded under the CIO-SP3 Small Business contract.

About TCG
TCG (https://www.tcg.com) delivers the positively distinct IT and management advisory services that propel America forward. We help government agencies achieve the amazing, saving taxpayers more than $1 billion.

About HeiTech Services, Inc.
HeiTech Services (http://www.heitechservices.com) provides Honorable, Excellent, and Innovative business processing and information technology solutions to the federal government. We are in business to help the federal government keep Americans safe.