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Clinical Trial Management and Regulatory Support

Active
Federal

Contract Overview

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

AI Contract Overview

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This contract involves providing comprehensive support for the clinical development of Medical Countermeasure (MCM) candidates. The scope of work includes designing clinical trial protocols, preparing and submitting regulatory documents such as Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, facilitating engagement with the FDA, and overseeing clinical trial sites. The Department of Defense, through its W6QK Acc-Apg office, will have government review rights to ensure compliance and proper execution. The contract is categorized as a subcontract under the NAICS code 541612 and is set to be performed in Frederick. The solicitation was posted on June 3, 2026, with a response deadline of June 22, 2026. Its primary focus is on clinical trial management and regulatory support aimed at advancing MCM candidates through critical development phases, ensuring adherence to regulatory requirements, and maintaining effective communication with federal oversight bodies.

General Info

Subcontract for clinical trial design, regulatory submissions, FDA engagement, and DoD compliance review.

Agency

Department Of Defense → W6QK Acc-Apg

NAICS

541612 - Human Resources Consulting Services View NAICS

Place of Performance

Frederick, MD, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

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Response Deadline

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Organization & Contact Information

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AgencyDepartment Of Defense → W6QK Acc-Apg
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Defense → W6QK Acc-Apg
Office AddressN/A
ContactsNo contact information available

Full Description

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Support clinical development of MCM candidates including protocol design, regulatory submissions (IND/IDE), FDA engagement, and oversight of clinical trial sites with government review rights.

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