SAM #7571TE26Q00184

Sole Source Notice: NIH/NIAID eCTD System and Services from Lorenz Life Sciences Group

This notice announces the NIH/NIAID's intent to award a sole source contract for an Electronic Common Technical Document (eCTD) system and related services. - Agency: National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Department of Health and Human Services (HHS) - Sole Source Vendor: Lorenz Life Sciences Group - Purpose: Acquisition of an eCTD system to support FDA-mandated regulatory submissions - Includes system upgrades, secure document repository with role-based access, and integration with eCTD tools - Features required: eCTD Validator, eCTD Viewer, assembly, management, compilation, publishing, validation, and review capabilities - Must provide access for Clinical Research Organizations (CROs) outside the NIH intranet - No specific part numbers or quantities provided - Notice issued under FAR 13.106-1(b) as a Notice of Intent to Sole Source - Not a solicitation; commercial vendors may respond if they can meet requirements

Description

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 Group is the only organization who can provide the services needed.

This is not a solicitation, nor is a solicitation available. However, all interested organizations may submit their capability statements and qualifications which will be considered by NIH. Responses must be in writing and must be submitted electronically to Damian Hurge, Contract Specialist at Damian.Hurge@HHS.gov  by 11:00 AM EST on, August 18, 2026. Proposals must include pricing information. No late responses will be accepted.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information.

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