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Regulatory Strategy and Submission Support

Active

Federal

Response Deadline06/24/2026, 04:00:00 PM UTC

Contract Overview

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

AI Contract Overview

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The contract involves providing expertise in regulatory strategy and submission support, specifically focused on developing regulatory pathways and preparing documentation for FDA approval of diagnostic and biological products. This includes tasks such as preparing Investigational New Drug (IND) applications and 510(k) submissions, which are critical for bringing medical products to market in compliance with regulatory standards. Issued by the Defense Advanced Research Projects Agency under the Department of Defense, the subcontract falls under the NAICS code 541611, indicating it is classified within administrative management and general management consulting services. The contract was posted on May 27, 2026, with a response deadline set for June 24, 2026. Details such as the exact location of performance, specific points of contact, or set-aside information are not provided. This opportunity supports strategic regulatory guidance essential for advancing diagnostics and biological products through the FDA’s approval process.

General Info

Provide regulatory strategy and FDA submission support for diagnostic and biological product approvals.

Agency

Department Of Defense → Defense Advanced Research Projects Agcy

NAICS

541611 - Administrative Management and General Management Consulting Services View NAICS

Place of Performance

VA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedMay 27

subcontract

Response DeadlineJun 24

Submission deadline

Response Deadline

06/24/2026, 04:00:00 PM UTCin 8 days

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Organization & Contact Information

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AgencyDepartment Of Defense → Defense Advanced Research Projects Agcy

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Defense → Defense Advanced Research Projects Agcy

Office AddressN/A

ContactsNo contact information available

Full Description

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Develop regulatory pathways and prepare submissions such as IND and 510(k) applications for FDA approval of diagnostics and biological products.

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