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Regulatory Compliance and Application Support

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Contract Overview

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

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The Regulatory Compliance and Application Support subcontract, issued by the Department of the Army under the Department of Defense, focuses on the preparation and submission of regulatory applications for prime contractors involved in DHA and DoD research projects. The scope of work includes managing FDA sponsor applications, ensuring strict adherence to 45 CFR 46.102, and creating clinical monitoring plans designed to mitigate operational risks. To qualify, personnel must possess a Regulatory Affairs Certification or demonstrate equivalent expertise in FDA guidelines. The primary deliverables for this engagement are comprehensive regulatory submission packages and detailed Clinical Monitoring Plans. This effort falls under NAICS code 541690 and is managed through the USAMRAA office.

General Info

Army subcontract for FDA regulatory applications and clinical monitoring plans for DoD research.

Agency

Department Of Defense → Department Of The Army -- Usamraa

NAICS

541690 - Other Scientific and Technical Consulting Services

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of HT942526ORPCRA.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

DoW Orthopaedic, Clinical Research Award

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Timeline

PostedMay 21

subcontract

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Organization & Contact Information

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AgencyDepartment Of Defense → Department Of The Army -- Usamraa

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Defense → Department Of The Army -- Usamraa

Office AddressN/A

ContactsNo contact information available

Full Description

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Performs regulatory application preparation and submission for prime contractors on DHA/DoD research projects. Manages FDA sponsor applications, ensures compliance with 45 CFR 46.102, and develops clinical monitoring plans to mitigate risk. Requires Regulatory Affairs Certification (RAC) or equivalent FDA guideline expertise. Delivers regulatory submission packages and Clinical Monitoring Plans.

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