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IND- or IDE-Enabling Nonclinical Studies

Active
SBIR / STTR

Contract Overview

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

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The Department of Health and Human Services is seeking a subcontractor to conduct GLP-compliant toxicology, pharmacokinetics, and biodistribution studies. These nonclinical studies are intended to support regulatory submissions for Investigational New Drug or Investigational Device Exemption applications. This opportunity is a total small business set-aside under the SBIR/STTR mandate for companies with fewer than 500 employees, categorized under NAICS code 541715. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.

General Info

HHS seeks small business subcontractors for GLP-compliant nonclinical toxicology and pharmacokinetics studies.

Agency

Department of Health and Human ServicesView Agency

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)View NAICS

Place of Performance

Not specified

Set-Aside

SBA

Documents

This scope was carved out of PAR-27-098.

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

View the prime solicitation

SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)

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Timeline

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Organization & Contact Information

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AgencyDepartment of Health and Human Services
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department of Health and Human Services
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Office AddressN/A
ContactsNo contact information available

Full Description

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Perform GLP-compliant toxicology, pharmacokinetics, and biodistribution studies to support regulatory submissions for IND or IDE applications.

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