Accenture StartingPoint Common Technical Document Templates

Statement of Need (SoN)

The Defense Health Agency Research and Development (DHA R&D) Office of Regulated Activities (ORA) requires Common Technical Document (CTD) authoring templates, training, and maintenance to support the development of U.S. Food and Drug Administration (FDA) regulated medical products for the warfighter.

Task 1 – Supply Support:

• Provide a complete set of granular CTD templates (Modules 1-5) including appendices, a style guide, and administration files.
• Templates should support various FDA application types: IND, NDA, ANDA, BLA, IDE, 510(k), PMA.
• Templates must include macro functionality for increased efficiency and formatting consistency (e.g., single-click tools, reference manager, cross-linking, TOC/LOT/LOF generation, auto-updating fields).
• Templates should allow application of formatting to existing documents.
• Incorporate instructional text, formatting standards, and guidance from FDA, ICH, and TransCelerate BioPharma.
• Provide user guides and technical documents.

Task 2 – Technical Accessibility:

• Ensure all technical data is accessible.
• Templates must be compatible with EDMS (Open Text Content Server).
• Compatibility required with current Army desktop operating systems and office productivity software (e.g., Windows 10, Microsoft Word 2013/2016, Office 365).
• Ensure compatibility with Adobe Acrobat pdf maker/conversion and eCTD publishing software.
• Templates must be usable by personnel without direct access to ORA’s internal network drives.

Task 3 – Training and Training Support:

• Provide a Training Plan for DoD Medical Writing Staff and Systems Managers.
• Training topics include installation, software applications, use instructions, troubleshooting, and updates.
• Provide all available user/maintainer manuals, training videos, and documentation.
• Offer individual and group training options.

Task 4 – Compliance Planning and Management:

• CTD Templates must remain compliant with current U.S. FDA and ICH recommendations.

• Provide a 12-month warranty covering parts, software updates, labor, and technical support.

• Notify the Army of all system-affecting notices for the system's useful life.

• Anticipated 5-year contract (base year + four option years).

• Base Year: May 4, 2026 – May 3, 2027 (15 units)

• Option Years 1-4: May 4, 2027 – May 3, 2031 (15 units per year)

Work and deliveries will not occur on specified Federal holidays. Observance dates may shift if holidays fall on weekends.

Request for Information (RFI) / Sources Sought

This RFI/Sources Sought (SS) is issued by the Defense Health Agency Contracting Activity (DHACA) for informational and planning purposes. It seeks industry feedback on capabilities for providing subscription-based authoring templates, training, and maintenance for the StartingPoint Common Technical Document (CTD) for the Defense Health Agency (DHA) Research & Development (R&D) Office of Regulated Activities (ORA).

The ORA supports the development of FDA-regulated medical products for the warfighter. They require standardized CTD authoring and reviewing tools to ensure efficiency, consistency, and compliance with FDA and ICH standards. The ORA currently uses Microsoft Word macro-based templates and is exploring options for cloud-based solutions compatible with evolving security postures and platforms.

Vendors should describe how their solutions address:

• Supply Support & Template Functionality: Comprehensive CTD templates (Modules 1-5) for all U.S. FDA application types, macro functionalities for efficiency (e.g., cross-linking, automated TOC), ability to apply templates to existing documents, incorporation of regulatory guidance, and access to user guides.
• Technical Accessibility & Compatibility: Compatibility with current Army desktop OS and software (Windows 10, Word 2013/2016, Office 365), EDMS (Open Text Content Server), Adobe Acrobat, eCTD publishing software, and usability by personnel without direct internal network access.
• Training and Support: A training plan for DoD staff, availability of user/maintainer manuals and videos, and options for on-demand training.
• Compliance and Maintenance: A process for ensuring templates remain compliant with current FDA/ICH regulations and the ability to provide periodic updates for a potential five-year period.

Submit a Capability Statement (max 10 pages) including:

• Company contact information and point of contact.
• Unique Entity ID, CAGE Code, company structure, and SAM registration.
• Any relevant Government IDIQ Contracts.
• Specific and relevant experience with similar projects, including examples or references.
• Information on capabilities, novel ideas, and best practices meeting the government's requirements.

Responses are due no later than April 15, 2026, at 12:00 PM ET. Submit electronically to kevin.t.jandovitz.civ@health.mil.

This RFI/SS is for information only and does not constitute a solicitation or commitment to award a contract. No evaluation letters will be issued. Responses will not be treated as proposals.