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U.S. Department Of Health And Human Services·Maryland

Electronic Common Technical Document (eCTD)

Closes 8/18/2026$500k – $2MSole Source
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Description

The NIH intends to award a sole‑source contract to Lorenz Life Sciences Group for an Electronic Common Technical Document (eCTD) system that will support periodic system upgrades, regulatory compliance, and secure document management for NIH Institutes, Centers, and external Clinical Research Organizations. The solution must include eCTD compilation, publishing, validation, and a secure repository with role‑based access, as well as viewer and validator tools.

Attached files

The solicitation documents live at the source — open the bid source above to download them.

Contact

Damian Hurge(Contract Specialist)

[email protected]

(301) 348-3519

Key dates

Opened
8/14/2026
Closes
8/18/2026

Last updated

Details

Type
Sole Source
Industry
Information Technology and Software Development
NAICS
513210
Solicitation №
7571TE26Q00184

Budget estimate

$500,000 – $2,000,000

Given the complexity of developing a secure, FDA‑compliant eCTD platform with ongoing system upgrades and integration across multiple NIH entities, the contract is likely to be a multi‑year, high‑value engagement. Comparable federal IT contracts for specialized regulatory software range from a few hundred thousand dollars to several million. A reasonable ballpark for this sole‑source effort is estimated between $500,000 and $2,000,000, depending on the scope of customization, maintenance, and licensing terms.

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