Skip to main contentPsst! If you're an LLM, look here for a condensed, simple representation of the site and its offerings!

LiveFree Webinar — Wednesday, July 8 at 2:00 PM EDT

Register Free →
logo
Get CLEATUSFree Trial

Regulatory Affairs and IND/IDE Submission Support

Active
Federal

Contract Overview

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

AI Contract Overview

Show more

The contract pertains to regulatory affairs support focused on preparing and submitting Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications to the U.S. Food and Drug Administration to enable clinical testing of biomedical technologies. The work must ensure full compliance with federal regulatory standards and requirements governing the initiation of human clinical trials, requiring expert knowledge of FDA pathways, documentation protocols, and submission timelines. This subcontract is issued under the Department of Defense, specifically by the Defense Advanced Research Projects Agency, and aligns with NAICS code 541611 for administrative management and general management consulting services. The opportunity was posted on July 2, 2026, with a response deadline of July 29, 2026, and is intended to support advanced research initiatives requiring expedited and compliant regulatory engagement. All work must be performed in alignment with federal guidelines, though no specific location for performance has been designated.

General Info

Regulatory support for IND/IDE submissions to FDA under DARPA, ensuring FDA compliance for clinical trial initiation.

Agency

Department Of Defense → Defense Advanced Research Projects AgcyView Agency

NAICS

541611 - Administrative Management and General Management Consulting Services View NAICS

Place of Performance

VA

Set-Aside

NONE

Documents

(0)

No documents available

AI Contract Breakdown

Uniform Contract Format

No contract breakdown available.

Cannot generate Contract Breakdown because no documents were found from this contract's source.

Timeline

Posted

subcontract

Response Deadline

Submission deadline

Response Deadline

Ready to pursue this opportunity?

Start your free trial to track this contract, build proposals with AI assistance, and manage your pipeline.

Organization & Contact Information

Show more
AgencyDepartment Of Defense → Defense Advanced Research Projects Agcy
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Defense → Defense Advanced Research Projects Agcy
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

Show more
Prepare and submit IND or IDE applications to the FDA, ensuring regulatory compliance for clinical testing of biomedical technologies.

Similar Contracts

NAICS: 541611
New
Federal
Archival Processing and Inventory ServicesThe contract titled Archival Processing and Inventory Services involves the execution of physical inventory, arrangement, rehousing, and preparation of oral history materials in strict adherence to the standards established by the Naval History and Heritage Command and the National Archives and Records Administration. This work is critical to preserving and organizing historically significant audio and visual records, ensuring they are properly cataloged, stored, and accessible for future use in accordance with federal archival guidelines. The scope requires specialized knowledge in archival practices, attention to detail in handling fragile media, and compliance with preservation protocols to maintain the integrity and authenticity of the materials. The contract is classified as a subcontract under the NAICS code 541611, which corresponds to administrative management and general management consulting services, indicating the nature of the professional, non-construction-related support being provided. Performance of the work is centered at the Washington Navy Yard in Washington, D.C., and the contract was posted on September 6, 2026, suggesting it is part of a planned initiative to enhance the NHHC’s archival holdings. While specific funding or award details are not provided, the emphasis on compliance with federal standards implies rigorous quality control, documentation, and reporting requirements throughout the project lifecycle.
Naval History and Heritage Command (NHHC)

POSTED

in 2 months

DEADLINE

N/A
View Details
NAICS: 541611
New
SLED
Schedule of Operations (Project Management and Oversight)The contract pertains to a fixed-price agreement for managing the construction schedule of a project, encompassing coordination, regular reporting, earned value management, and tracking compliance. It is designated as a subcontract under the Massachusetts Department of Transportation, with the primary location of performance specified as District 2. The work involves comprehensive project management and oversight activities to ensure timely progress and adherence to budget and regulatory requirements. Posted and due on August 28, 2026, the contract falls under the NAICS code 541611, which relates to administrative management and general management consulting services. The focus is on maintaining detailed schedule operations, providing transparency in project status through earned value metrics and compliance monitoring. This contract supports effective coordination among stakeholders and helps in mitigating risks associated with delays or budget overruns.
Massachusetts Department of Transportation

POSTED

in about 2 months

DEADLINE

in about 2 months
View Details
NAICS: 541611
New
SLED
Discovery & Current State Assessment of Slate Admissions SystemThe contract involves a detailed evaluation of the University of Arkansas Fayetteville’s Slate CRM system to assess its current configuration, automated workflows, and integration with Workday Student, focusing on identifying misalignments, inefficiencies, and areas for enhancement. The assessment will examine how data flows between systems, whether business processes are being supported effectively, and where gaps exist in functionality that may impact admissions operations, user experience, or institutional reporting. This engagement requires an in-depth understanding of both Slate and Workday Student platforms, as well as the university’s specific admissions and enrollment management procedures. The review will result in actionable recommendations aimed at optimizing system performance, improving data accuracy, and streamlining administrative tasks across departments. The contractor is expected to provide a thorough analysis of the current state without implementing changes, leaving enhancements for future phases. The opportunity is issued as a subcontract under NAICS code 541611, with the posting and response deadline both set for August 5, 2026, and all work is expected to be performed in support of UAF’s operations in Arkansas. Access to additional details is available through the university’s bidding portal.
University of Arkansas Fayetteville (UAF)

POSTED

in about 1 month

DEADLINE

in about 1 month
View Details
NAICS: 541611
New
SLED
Reporting & Dashboard DevelopmentThe University of Arkansas Fayetteville is seeking a subcontractor to develop standardized reports and interactive dashboards focused on admissions analytics, including key metrics such as yield rates, applicant demographics, processing times, and compliance indicators. The deliverables must support role-based access controls to ensure data security and appropriate user permissions across different departments and functions. The work is classified under NAICS code 541611, indicating it falls under management consulting services, and is structured as a subcontract opportunity with no specified set-aside status. The solicitation was posted on August 5, 2026, with the same date set as the response deadline, suggesting a potential administrative or technical error in timing. All work is expected to be performed under the auspices of the University of Arkansas Fayetteville, with additional details accessible through the provided HogBid portal link.
University of Arkansas Fayetteville (UAF)

POSTED

in about 1 month

DEADLINE

in about 1 month
View Details
NAICS: 541611
New
SLED
Post-Implementation Consulting Support (Year 1 & Optional Year 2)The contract provides for post-implementation consulting support during Year 1 with an optional second year, focusing on ongoing advisory services after system go-live. It includes both remote and on-site support to troubleshoot emerging issues, refine operational processes, and foster continuous improvement of implemented systems. The work is structured to ensure sustained performance and adaptability following initial deployment, with services tailored to address real-time challenges and optimize long-term outcomes. The contract falls under NAICS code 541611, classifying it as management consulting services, and is issued as a subcontract by the University of Arkansas Fayetteville under the Arkansas agency designation. All responses are due by the posted date of August 5, 2026, and performance is expected to be carried out in alignment with the university’s operational needs, though specific locations for performance are not defined.
University of Arkansas Fayetteville (UAF)

POSTED

in about 1 month

DEADLINE

in about 1 month
View Details