Electronic Common Technical Document Ectd Tender in USA - 147287567

Procurement Summary

Country: USA

Summary: Electronic Common Technical Document Ectd

Deadline: 18 Aug 2026

Posting Date: 15 Aug 2026

Other Information

Notice Type: Tender

TOT Ref.No.: 147287567

Document Ref. No.: 7571TE26Q00184

Competition: ICB

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

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Tender Details

Solicitation Number: 7571TE26Q00184
Notice Type: Notice of Intent to Sole Source
Title: Electronic Common Technical Document (eCTD)
Description:
The National Institute of Health (NIH) intends to award a sole source purchase order for National Institutes of Allergy and Infectious Diseases (NIAID), for O Electronic Common Technical Document (eCTD). The North American Industry Classification System Code (NAICS) is 513210.
Lorenz Life Sciences Group is the only responsible source known to provide the services needed.
It is NIH's intent that the proposed action may be awarded on a sole source basis to Lorenz Life Sciences Group under the authority of Federal Acquisition Regulation (FAR) Subpart 13 Simplified Acquisition Procedures.
Contractor Objectives and Tasks:
The purpose of this acquisition is to acquire Electronic Common Technical Document (eCTD) for the purpose of performing periodic System upgrades is to maintain regulatory compliance, including ensuring adherence to current industry standards and minimizing security vulnerabilities.
This includes:
• Provides Institutes and Centers (ICs) and Clinical Research Organizations (CROs) with the ability to support the assembly and management of eCTD packages, compliant with relevant regulatory and Computer System Validation (CSV) guidelines and requirements.
• Allows compilation, publishing, validation, and review of FDA mandated regulatory submissions, such as US INDs (Investigational New drug) and US DMF-s (Drug Master File).
• Provides CROs with access to the System functionality from outside NIH Intranet.
• Provide a secure document repository for the storage of Sponsor documents with role-based access controls.
• Ensures integration of the secure document repository with the eCTD compilation and publishing tool.
o eCTD Validator
o eCTD Viewer
Sole Source Justification
In accordance with FAR 13.106-1(b), Soliciting from a Single Source, Lorenz Life Sciences...
Notice ID: 7571te26q00184

Department/Ind. Agency: health and human services, department of

Sub-tier: office of the assistant secretary for financial resources (asfr)

Product Service Code: da01 - it and telecom - business application/application development support services (labor)

NAICS Code: 513210 - Software Publishers

Inactive Dates: sep 02, 2026

Inactive Policy: 15 days after response date

Disclaimer: The deadline date mentioned is tentative and provided for informational purposes only. This notice is a procurement forecast or general procurement plan, and not an active tender. Suppliers are advised to refer to the original documents and contact the issuing authority directly for the official tender release date and further details

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