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

The Defense Health Agency Contracting Activity seeks Electronic Common Technical Document (eCTD) software licenses, maintenance, technical support services, and training for eCTD publishing and reviewing software products and modules, with proposals due July 8, 2026 and questions due June 11, 2026. This is a 100% total small business set-aside under NAICS code 513210 (Software Publishers), with a small business size standard of $47.0 million.

Place of performance is Frederick, Maryland, with work performed remotely during standard business hours (Monday through Friday, excluding federal holidays) and travel to Fort Detrick, Maryland required for in-person training and technical consulting as needed. The requirement encompasses twelve eCTD Publisher user licenses, fifty named eCTD Reviewer user accounts, FDA-mandated submission templates, technical support services, training services, and consulting services.

The software must support Microsoft Windows Server 2019 R2 (64-bit) or newer, interface with OpenText Content Server 22.4 and current releases, comply with FDA 21 CFR Part 11 requirements, and be deployable in on-premise configurations or vendor-hosted FedRAMP-approved cloud environments in accordance with CMMC standards. The contractor must achieve Risk Management Framework (RMF) Authority to Operate (ATO) certification, CMMC Level 1 compliance with self-assessment prior to award, and HIPAA Privacy Rule compliance. All contractor personnel must execute a DHA Non-Disclosure Agreement prior to commencing work and annually thereafter, and must hold TIER II non-critical sensitive position clearances.

The contract includes a base period from July 15, 2026 through July 14, 2027, followed by four one-year option periods and a six-month extension, totaling 5.5 years. Pricing is firm fixed price for software licenses, maintenance, and technical support; cost with no fee (reimbursable) for training and travel with plugged not-to-exceed amounts ranging from $1,500 to $9,004.07 across contract periods. Amendment 0001, issued June 23, 2026, extended the proposal deadline from July 6 to July 8, 2026, corrected the questions due date, and amended the PWS based on vendor questions and government responses.