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

Solicitation / RFP / RFQ

This solicitation (RFP HT942726RE005) is for the procurement of 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 (DHACA) is issuing this RFP on behalf of the Enterprise Information Technology (eIT) Project Management Office (eIT PMO).

• Software licenses and maintenance for twelve (12) eCTD Publishing User Accounts and up to fifty (50) named eCTD Reviewer Accounts.

• FDA-mandated submission templates.

• Technical support services for resolving application problems.

• Training services for both eCTD publishing and reviewing users.

• FDA-validated software installation support and scripts.

• Consulting services to support regulatory questions by eCTD publishers.

• The eCTD software must interface with OpenText Content Server 22.4 and current releases.

• The eCTD software must support Microsoft Windows Server 2019 R2 (64-bit) operating system and newer.

• The eCTD software must meet U.S. Food & Drug Administration (FDA) 21 CFR Part 11 requirements.

• The eCTD software must be capable of being installed on-premise and in the cloud.

• Contract Type: Firm-Fixed-Price (FFP) for software licenses and maintenance; other services may be cost-reimbursable or cost-no-fee.

• Period of Performance: Anticipated 15 July 2026 through 14 January 2032 (Base Period + 4 Option Periods + 6-month extension), totaling approximately 5.5 years.

• Place of Performance: Remote.

• Solicitation Issue Date: 08 Jun 2026

• Questions Due Date/Local Time: 11 Jun 2026, 04:00 PM Eastern Daylight Time (Note: This conflicts with information on page 107).

• Offer Due Date/Local Time: 06 Jul 2026, 4:00 PM Eastern Daylight Time.

• Proposals must be submitted electronically via email to toloria.s.duvall.civ@health.mil and kelly.r.green.civ@health.mil in Microsoft Word, Excel, or Adobe PDF format.

• Proposals are limited to 20 single-sided pages for the non-price proposal (excluding Table of Contents, Cover Page, and Exhibits).

• Evaluation Factors: Technical Approach, Experience, Management Approach, Past Performance, and Price. Technical Approach, Experience, and Management Approach are considered more important than Past Performance, which is more important than Price. A "best value tradeoff" process will be used.

• This requirement is being solicited competitively as a 100% total small business set-aside.

• NAICS Code: 513210 (Software Publishers)

• Small Business Size Standard: $47.0M

• Offerors must be registered in the System for Award Management (SAM) database.

• Cybersecurity Maturity Model Certification (CMMC) Level 1 self-assessment is required.

• Offerors must be aware of System for Award Management (SAM) and Cybersecurity Maturity Model Certification (CMMC) requirements and not wait to initiate these processes.

Performance Work Statement (PWS)

This PWS outlines the requirements for providing Electronic Common Technical Document (eCTD) software licenses, maintenance, technical support services, and training for eCTD publishing and reviewing software products and modules. The system is intended for use by the Enterprise Information Technology (eIT) Project Management Office (PMO) for preparing and managing electronic regulatory submissions.

• Provide commercial off-the-shelf (COTS) eCTD publishing and reviewing software licenses and maintenance.

• Offer technical support services for installation, upgrades, and validation.

• Provide training services for eCTD publishing and reviewing users.

• Supply FDA-mandated submission templates.

• Support FDA-validated software installation and scripts.

• Provide non-personal services to address regulatory questions.

• Acquire licenses for twelve (12) eCTD Publisher user accounts and up to fifty (50) named eCTD reviewer accounts.

• Base Period: July 15, 2026 – January 14, 2032.

• Four (4) one-year renewable options and a six (6) month extension.

• Work will be performed remotely.

• Contractor must develop and maintain an effective Quality Control (QC) program.

• Government will evaluate performance using a Quality Assurance Surveillance Plan (QASP).

• Specific performance objectives and acceptable quality levels are detailed in Attachment 1.

• Contractor personnel must comply with DoD cybersecurity and personal security requirements, including background investigations and Non-Disclosure Agreements (NDAs).

• All work is unclassified.

• Compliance with specific IT and cybersecurity regulations (e.g., HIPAA, RMF, CMMC Level 1) is required.

• Contractor must use the PIEE/GFP Module for Government Furnished Property (GFP) management.

• Contractor personnel must identify themselves as contractor support personnel in all communications.