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

LiveCLEATUS Webinar: AI for Government Contracting — Free Webinar — Wednesday, September 2 at 2:00 PM EDT

Register Free →

Search

Top

Back to Contracts

Regulatory and Clinical Validation Support

Active

Federal

Response Deadline09/04/2026, 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

Show more

This subcontract opportunity with the Advanced Research Projects Agency for Health under the Department of Health and Human Services focuses on providing regulatory and clinical validation support. The selected provider will be responsible for developing regulatory strategies, performing gap analyses, creating test protocols, and offering guidance for FDA submissions specifically for novel diagnostic tools utilized in drug quality assurance. The solicitation was posted on August 20, 2026, with a response deadline of September 4, 2026. Classified under NAICS code 541690, the performance of this contract is centered in the 20005 zip code area.

General Info

ARPA-H subcontract for regulatory and clinical validation support for novel diagnostic tools.

Agency

Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)View Agency

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

DC, 20005, USA

Set-Aside

NONE

Documents

This scope was carved out of ARPA-H-SN-26-160.

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

View the prime solicitation

Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and SupplieS (FASTPASS) Proposers' Day

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

PostedAug 20

subcontract

Response DeadlineSep 4

Submission deadline

Response Deadline

09/04/2026, 04:00:00 PM UTCin 6 days

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 Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)

View Agency Profile

Office AddressN/A

ContactsNo contact information available

Full Description

Show more

Provide regulatory strategy, gap analysis, test protocol development, and FDA submission guidance for novel diagnostic tools used in drug quality assurance.

Similar Contracts

Same NAICS industry code

Corydon Well Replacement Project – Professional Design, Bidding Support and Engineering Services During Construction

Solicitation # C2305

The Elsinore Valley Municipal Water District (EVMWD) is soliciting proposals for the Corydon Well Replacement Project, which involves the professional design, bidding support, and engineering services required to replace and abandon the existing Corydon well in Wildomar, California. The project is divided into two primary phases: Phase 1 focuses on civil site design, technical specifications, and construction management for the drilling of the new well and abandonment of the old one; Phase 2 covers the architectural, civil, mechanical, structural, electrical, and instrumentation design for equipping, testing, and commissioning the new groundwater production well. The project is funded through District funds and a Department of the Interior Bureau of Reclamation WaterSMART Planning and Project Design Grant, necessitating compliance with federal requirements, including the Build America Act, Buy America Preference, and the use of the Automated Standard Application for Payments (ASAP) system. TKE Engineering, Inc. is seeking qualified DBE, MBE, and WBE firms specializing in hydrology/hydraulic consulting, structural and electrical engineering, geotechnical investigation, and utility potholing. Proposals are due by 10:00 a.m. on September 1, 2026, via the PlanetBids Vendor Portal. Selection is based on demonstrated competence and professional qualifications, with evaluation weighted toward relevant experience (25%), project approach (25%), and scope/schedule (20%), while cost and innovation each account for 10%. The total estimated project cost is 2,260,788 dollars, though the final contract will be a negotiated not-to-exceed dollar limit. Awardees must adhere to strict federal and state regulations, including whistleblower protections, drug-free workplace standards, and specific insurance and bonding requirements for contracts exceeding the simplified acquisition threshold.

TKE Engineering, Inc.

POSTED

about 15 hours ago

DEADLINE

Field Deployment and Technical Support Services

Florida Fish and Wildlife Conservation Commission

POSTED

about 23 hours ago

DEADLINE

Hazardous Materials Communication & LabelingThis subcontract opportunity with the Department of Defense ASC Commodities Division focuses on Hazardous Materials Communication and Labeling. The primary objective is to ensure full compliance with the OSHA HazCom standard, specifically regarding the preparation of Safety Data Sheets and the proper labeling of hazardous materials for all delivered items. The project is associated with NAICS code 541690 and will be performed at Tinker AFB, zip code 73145-8000. The solicitation was posted on August 28, 2026, with a response deadline of September 2, 2026.

ASC COMMODITIES DIVISION

POSTED

DEADLINE

Hazardous Materials Compliance and LabelingThe Department of Defense, specifically the ASC Supplier Oper AE and AF Div, is seeking a subcontractor for hazardous materials compliance and labeling. The primary objective of this contract is to ensure all hazardous materials are handled in accordance with safety regulations, which includes the preparation of Safety Data Sheets and the application of labeling that adheres to OSHA HAZCOM and Federal Standard No. 313. This opportunity falls under NAICS code 541690 and was posted on August 28, 2026. Interested parties must submit their responses by the deadline of September 17, 2026. Further details and submission guidelines can be accessed through the provided DIBBS solicitation link.

ASC SUPPLIER OPER AE AND AF DIV

POSTED

DEADLINE

Hazardous Materials Compliance and Labeling ServicesThe Department of Defense, through the ASC Commodities Division, is seeking a subcontractor to provide specialized consultation and documentation services focused on hazardous materials compliance. The primary objective of this engagement is to ensure all labeling and safety data sheets strictly adhere to OSHA and DLA requirements. This subcontract opportunity is associated with NAICS code 541690 and will be performed at Tinker AFB, Oklahoma. Interested parties must submit their responses by September 2, 2026, following the posting date of August 28, 2026.

ASC COMMODITIES DIVISION

POSTED

DEADLINE

Hazardous Materials Compliance and Safety Data Management

ASC COMMODITIES DIVISION

POSTED

DEADLINE

Traffic Control and Flagging Services

Department of Economic Development

POSTED

DEADLINE

Pool of Vendors, Master Order to Provide Academic Affairs and Accreditation Consulting Services

Solicitation # TAMHSC-ITB-26-0649

Texas A&M University System Health Science Center is seeking qualified consulting firms to establish a pool of vendors for Academic Affairs and Accreditation Consulting Services. The scope of work includes providing expertise in Academic Affairs assessment, LCME accreditation, and clinical education network consulting. This solicitation, identified as TAMHSC-ITB-26-0649, was posted on August 28, 2026, with a response deadline of September 18, 2026, at 8:00 PM. Interested parties should coordinate with the primary point of contact, Kristina Kanevsky, for further inquiries regarding this Texas-based engagement.

Texas A&M University System Health Science Center

POSTED

DEADLINE

Pool of Vendors, Master Order to Provide Academic Affairs and Accreditation Consulting Services

Solicitation # TAMHSC-ITB-26-0649

Texas A&M University is soliciting qualified consulting firms to establish a pool of vendors for Academic Affairs and accreditation consulting services. The scope of work focuses on providing expertise in Academic Affairs assessment, LCME accreditation, and the development of clinical education networks. This solicitation, identified as TAMU-TAMHSC-ITB-26-0649, was posted on August 28, 2026, with a response deadline of September 18, 2026. Interested parties should coordinate with the primary point of contact, Kristina Kanevsky, and submit their proposals through the designated procurement portal.

Texas A&M University

POSTED

DEADLINE

Confined Space Entry Planning

POSTED

DEADLINE

Technical Reporting and Documentation Services

Puget Sound Naval Shipyard IMF

POSTED

DEADLINE

Remote Technical Support and Troubleshooting

Department Of Commerce Noaa

POSTED

DEADLINE

More opportunities from Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)

Same awarding agency

Quality Assurance & Data Validation ServicesThe Advanced Research Projects Agency for Health, under the Department of Health and Human Services, is seeking a subcontractor for Quality Assurance and Data Validation Services. The primary objective of this contract is to perform independent reviews and validations of analytical data to ensure strict compliance with method validation criteria. Key technical focus areas include the assessment of calibration linearity, spike recovery accuracy, intra-day and inter-day precision, and the determination of limit of detection and limit of quantification. This opportunity is categorized under NAICS code 541690 and was posted on August 24, 2026. Interested parties must submit their responses by the deadline of September 8, 2026. The performance of these services is associated with location 77416.

Other Scientific and Technical Consulting Services

POSTED

DEADLINE

Polymer Reference Standards & Calibration Materials SupplyThis subcontract through the Advanced Research Projects Agency for Health under the Department of Health and Human Services involves the supply of high-purity, traceable reference standards for nine specific target polymers, including PE, PP, PVC, PET, Ny-6, PS, PMMA, PU, and SBR. These materials are required for method calibration, spike recovery testing, and quality control processes during Py-GC/MS analysis. The opportunity was posted on August 24, 2026, with a response deadline of September 8, 2026. It is categorized under NAICS code 424690 and specifies a place of performance in the 77416 zip code area.

Other Chemical and Allied Products Merchant Wholesalers

POSTED

DEADLINE

Biological Sample Preparation & HandlingThis subcontract opportunity with the Advanced Research Projects Agency for Health under the Department of Health and Human Services focuses on the specialized preparation and handling of human biological samples, including blood, urine, and tissue. The primary objective is to facilitate micro- and nanoplastics analysis through critical processes such as homogenization, lipid removal, and matrix isolation, all while ensuring sample integrity and preventing cross-contamination. The project is categorized under NAICS code 621790 and is scheduled for performance in the 77416 area. Interested parties must submit their responses by September 8, 2026, following the posting date of August 24, 2026.

POSTED

DEADLINE

ISO-7 Cleanroom Facility Operations & MaintenanceThis subcontract opportunity, titled ISO-7 Cleanroom Facility Operations and Maintenance, is issued by the Advanced Research Projects Agency for Health under the Department of Health and Human Services. The contract requires the provision and maintenance of an ISO-7 certified cleanroom designed for the contamination-free handling and analysis of biological samples. Key responsibilities include implementing environmental monitoring and maintaining detailed documentation of particulate control measures to ensure facility standards are met. The project falls under NAICS code 541380 and is located in the 77416 area. Interested parties must submit their responses by the deadline of September 8, 2026. This engagement focuses on high-level facility management to support critical biological research and analysis.

Testing Laboratories and Services

POSTED

DEADLINE

Py-GC/MS Method Development & ValidationThis subcontract through the Advanced Research Projects Agency for Health under the Department of Health and Human Services focuses on the development, optimization, and validation of a standardized pyrolysis-gas chromatography/mass spectrometry method. The primary objective is to enable the detection of nine specific polymers within biological samples, including tissue, blood, and urine. All technical work must be conducted within an ISO-7 cleanroom environment to ensure sample integrity and precision. The solicitation was posted on August 24, 2026, with a response deadline of September 8, 2026, and falls under NAICS code 541713.

Research and Development in Nanotechnology

POSTED

DEADLINE

Py-GC/MS for Micro- and Nanoplastic Analysis

Solicitation # 75N992-26-SS-106

The Advanced Research Projects Agency for Health (ARPA-H) Health Science Futures Office has issued a sources sought notice to evaluate industry interest and capabilities regarding specialized analytical services. The agency is seeking organizations with the expertise to provide gold-standard Pyrolysis-gas chromatography/mass spectrometry (Py-GC/MS) analysis. This technical requirement focuses on the detection and analysis of micro- and nanoplastics (MNPs) within various biological samples, including blood, urine, and tissue. This solicitation, identified by number 75N992-26-SS-106, serves as a market research tool to identify vendors with relevant experience in high-precision chemical analysis for health science applications. Interested parties must submit their responses by the deadline of September 8, 2026. The procurement falls under NAICS code 334516 and is managed by the Department of Health and Human Services.

Analytical Laboratory Instrument Manufacturing

POSTED

DEADLINE

Ruggedized Enclosures and Transportable Platform ComponentsThis subcontract opportunity with the Advanced Research Projects Agency for Health under the Department of Health and Human Services involves the supply of ruggedized enclosures, cases, and mounting hardware. These components are designed to protect sensitive sensor equipment operating within harsh port-of-entry environments. The project falls under NAICS code 332322 and is centered in the 20005 zip code area. The solicitation was posted on August 20, 2026, and requires a response by November 10, 2026. Interested parties can find further details and submission guidelines through the provided government workspace link.

Sheet Metal Work Manufacturing

POSTED

DEADLINE

Independent Verification and Validation (IV&V) TestingThe Independent Verification and Validation (IV&V) Testing subcontract is issued by the Advanced Research Projects Agency for Health (ARPA-H) under the Department of Health and Human Services. The selected party will act as an independent third party responsible for verifying and validating system performance against specific milestones and success criteria within realistic environments. This opportunity is categorized under NAICS code 541690 and is located in the 20005 zip code area. The solicitation was posted on August 20, 2026, with a response deadline of November 10, 2026.

Other Scientific and Technical Consulting Services

POSTED

DEADLINE

Visual Imaging and Machine-Readable Code IntegrationThis subcontract, issued by the Advanced Research Projects Agency for Health under the Department of Health and Human Services, focuses on the development and integration of visual imaging and machine-readable code systems. The primary objective is to establish a comprehensive documentation and audit trail linkage for every pharmaceutical sample processed. The opportunity was posted on August 20, 2026, with a response deadline of November 10, 2026. Classified under NAICS code 334613, the project will be performed in the 20005 zip code area.

Blank Magnetic and Optical Recording Media Manufacturing

POSTED

DEADLINE

System Integration and InteroperabilityThe System Integration and Interoperability subcontract, issued by the Advanced Research Projects Agency for Health under the Department of Health and Human Services, focuses on the development of a fieldable platform. The primary objective is to integrate sensor hardware and AI software, ensuring the creation of standardized data streams and middleware to facilitate seamless cross-system communication. This opportunity falls under NAICS code 541512 and was posted on August 20, 2026. Interested parties must submit their responses by the deadline of November 10, 2026. The performance of the contract is centered in the 20005 zip code area.

Computer Systems Design Services

POSTED

DEADLINE

Multi-Modal AI and Data Fusion Software DevelopmentThe Multi-Modal AI and Data Fusion Software Development subcontract, issued by the Advanced Research Projects Agency for Health under the Department of Health and Human Services, focuses on the creation of AI and ML algorithms for signal processing and data fusion. The primary objective is to develop real-time decision support systems capable of interpreting multi-sensor data to ensure the quality and safety of pharmaceutical drugs. This opportunity falls under NAICS code 541721 and is scheduled for performance in the 20005 zip code area. The solicitation was posted on August 20, 2026, with a final response deadline of November 10, 2026.

POSTED

DEADLINE

Advanced Non-Destructive Sensor DevelopmentThe Advanced Non-Destructive Sensor Development subcontract, issued by the Advanced Research Projects Agency for Health under the Department of Health and Human Services, focuses on the creation of ruggedized, field-deployable sensing technologies. The primary objective is to implement non-destructive pharmaceutical screening capabilities, utilizing methods such as Raman, NIR, and THz sensing, to identify substances through packaging at ports of entry. This opportunity falls under NAICS code 334510 and is scheduled for a response deadline of November 10, 2026. Performance for the contract is centered in the 20005 zip code area, with the project officially posted on August 20, 2026.

Electromedical and Electrotherapeutic Apparatus Manufacturing

POSTED

DEADLINE