SAM #HT9426-26-RFI-0023

DHA Subscription for Accenture StartingPoint CTD Templates, Training, and Maintenance

The Defense Health Agency (DHA) is seeking a subscription-based solution for Common Technical Document (CTD) authoring templates, training, and maintenance to support regulatory submissions to the FDA. - Government Buyer: - Defense Health Agency (DHA), Office of Regulated Activities (ORA) - Contracting office: Medical R&D Contracting Division 1 / Defense Health Agency Contracting Activity (DHACA), Fort Detrick, Maryland - OEMs and Vendors: - Accenture (OEM for StartingPoint CTD templates) - Products/Services Requested: - StartingPoint Common Technical Document (CTD) authoring templates (subscription-based) - Complete set for Modules 1-5, supporting all FDA application types (IND, NDA, ANDA, BLA, IDE, 510(k), PMA) - Includes macro functionalities, style guides, and administration files - Compatible with Army/DoD desktop systems - 15 units delivered annually (per Statement of Need) - Training and support services - Training plans for DoD Medical Writing Staff and Systems Managers - User/maintainer manuals, training videos, individual and group training options - Maintenance and compliance services - Periodic updates to ensure compliance with FDA and ICH standards - 12-month warranty covering parts, software updates, labor, technical support, and shipping - Unique or Notable Requirements: - Templates must support all sections of CTD Modules 1-5 and all FDA application types - Macro functionalities for efficiency and compatibility with DoD systems - Ongoing compliance with FDA and International Council for Harmonisation (ICH) regulations - Warranty and technical support for 12 months - Potential five-year period of performance (base year plus four option years) - Place of Performance/Delivery: - Fort Detrick, Frederick, Maryland (primary federal facility) - Defense Health Agency Research and Development (DHA R&D) Office of Regulated Activities (ORA)

Description

The ORA requires a subscription for StartingPoint Common Technical Document (CTD) authoring templates, training, and maintenance to facilitate standardized authoring and reviewing of documents intended for regulatory submissions to the FDA. The objective is to increase writing efficiency, maintain formatting consistency, and ensure compliance with FDA and International Council for Harmonisation (ICH) standards.

View original listing