Infotrend, an SBA designated 8(a) company, was awarded a 3-year contract for application development and electronic document management with the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER). G2Xchange notes that “This win builds on Infotrend’s prior experience providing support to the FDA Center for Drug Evaluation and Research (CDER) Electronic Submissions Program and adds to their broad set of past performance that cuts across numerous Federal Civilian and Financial agencies.”
This contract is an extension of the work that Infotrend has been doing for CDER’s Electronic Submissions Program (ESP) since 2019. Infotrend will continue developing and managing the electronic Common Technical Document (eCTD) application (running on Lorenz) as well as continue oversight and maintenance of the Automated Submission Receipt (ASR) system; both of which are used by the FDA to track and manage applications for new drugs. This contract creates a streamlined avenue for drug approval packages and has been critical over the course of the pandemic. The scope of this contract encompasses O&M and System Life Cycle Management support services including planning, design, development, testing and deployment, and ASR system upgrades.
“Because of our initial work with CDER’s ESP project, the FDA has shown a great deal of faith in Infotrend by awarding us this contract to continue our application development and electronic document management work. We look forward to continuing this crucial work, particularly after facing a pandemic that has shown the importance of a streamlined and efficient drug and biologic review process.”
– Gurpreet Singh, CEO, Infotrend
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