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Design History File (DHF) and Manufacturing Specifications Development

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The contract requires the development and delivery of a complete Design History File and final manufacturing specifications under the oversight of the CDC Office of Acquisition Services, with performance based in Atlanta, Georgia, 30329. The work is scoped to support the scale-up of a product or process, necessitating thorough documentation aligned with regulatory and quality standards to ensure traceability, consistency, and compliance throughout manufacturing transitions. The deliverables must reflect full adherence to CDC requirements and be submitted for review and approval prior to advancing production. This is a subcontract opportunity posted on July 24, 2026, with proposals due by July 29, 2026, and classified under NAICS code 541715 for research and development in the physical, engineering, and life sciences. The contracting entity operates under the U.S. Department of Health and Human Services, indicating that the project is tied to public health initiatives requiring rigorous documentation and oversight. While no set-aside designation is specified, the urgency of the deadline and the technical nature of the deliverables suggest the need for a qualified subcontractor with demonstrated experience in regulated manufacturing environments and design control systems.

General Info

Develop and deliver Design History File and manufacturing specs for CDC in Atlanta under strict regulatory compliance.

Agency

Department Of Health And Human Services → CDC Office Of Acquisition ServicesView Agency

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)View NAICS

Place of Performance

Atlanta, GA, 30329, USA

Set-Aside

NONE

Documents

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No documents available

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Timeline

Posted

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → CDC Office Of Acquisition Services
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → CDC Office Of Acquisition Services
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Office AddressN/A
ContactsNo contact information available

Full Description

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Compile and deliver a complete Design History File (DHF) and final manufacturing specifications to support scale-up under CDC oversight.

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