Electronic Common Technical Document (eCTD) Software License, Maintenance, Technical Support Services, and Training for eCTD Publishing and Reviewing Software Products and Modules

Summary (Newest Update)

Background The Defense Health Agency Contracting Activity (DHACA) is issuing this Request for Proposal (RFP) on behalf of the Enterprise Information Technology (eIT) Project Management Office (eIT PMO). The goal of this contract is to procure Electronic Common Technical Document (eCTD) Software License, Maintenance, Technical Support Services, and Training for eCTD Publishing and Reviewing Software Products and Modules. This requirement is being solicited competitively as a 100% total small business set-aside. Work Details The contractor shall provide commercial off-the-shelf (COTS) eCTD publishing and reviewing software licenses, maintenance, technical support services, and training. Specific requirements include: - Twelve (12) eCTD Publisher user accounts - Up to fifty (50) named eCTD reviewer accounts - FDA-mandated submission templates - Technical support services for application problems - Training services for both eCTD publishing and reviewing users - FDA-validated software installation support and scripts. The eCTD software must meet specific technical requirements including compatibility with OpenText Content Server 22.4, support for Microsoft Windows Server 2019 R2 or newer, and compliance with FDA 21 CFR Part 11. Period of Performance 15 July 2026 through 14 January 2032, with four one-year renewable options and a six-month extension. Place of Performance The work shall be performed remotely. Bidder Requirements Bidders must comply with the Small Business Set Aside - Total (SBA). Additionally, bidders must demonstrate that their software solution meets specific go/no-go requirements related to system compatibility and regulatory compliance. Incumbent Analysis (see Incumbents section for more detail) This opportunity appears to have a confirmed incumbent based on prior contract W81XWH21C0089, awarded to Lorenz International for $761,075 covering software licenses from 07/15/21 through 07/14/25. The current requirement similarly calls for COTS eCTD publishing and reviewing software licenses along with maintenance, technical support, and training, which suggests continuity from the earlier licensing effort into ongoing subscription/support and user enablement for the same type of eCTD software products.