AN41--Research Services Neural Stem Cell Study for Spinal Cord Injury
Awarded Limited / Sole Source Justification Posted
- Solicitation number
- 36C24E26R0021
- Agency
-
Veterans Integrated Service Network 4
Veterans Health Administration, Department of Veterans Affairs
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 36C24E26C0013-36C24E26C0013
- NAICS code
- 541380 Testing Laboratories and Services
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs Veterans Health Administration has awarded a sole-source contract to PHARMARON (SAN DIEGO) LAB SERVICES LLC for in vivo safety and efficacy testing of GMP H9-scNSCs under good laboratory practice conditions, with a contract value of $1,088,660.00 and an award date of September 17, 2026.
The justification cites FAR 6.302-1, only one responsible source. Market research confirmed no other Contract Research Organizations can provide the complete combination of required capabilities within the required timeline. Pharmaron's unique qualifications include extensive expertise in stem cell-based therapies integrated within a central nervous system-focused framework, established GLP toxicology and bioanalytical capabilities, capacity for long-duration immunocompromised animal studies, specialized housing and standard operating procedures, demonstrated experience with animal spinal cord injury models, location within required driving distance of the VA San Diego Healthcare System with ADA compliance, and ability to support FDA Investigational New Drug submissions.
The one-year firm fixed-price contract runs from September 1, 2026 through August 31, 2027. Key deliverables include study protocol completion, animal procurement and acclimation, lesion and transplant surgery, animal perfusion at 1-, 3-, and 9-month timepoints, clinical pathology assessments, and a final GLP-compliant study report in compliance with FDA 21 CFR Part 58. The contract is administered by the VA Regional Procurement Office-East in Pittsburgh, PA, on behalf of the VA San Diego Healthcare System Research Service. Place of performance is San Diego, California.
Notice text
Please see the attached Justification and Approval to sole source In vivo Safety/Efficacy of GMP H9-scNSCs (GLP) research services for the VA San Diego Healthcare System. Awarded contract 36C24E26C0013 to PHARMARON (SAN DIEGO) LAB SERVICES LLC for 1088660.00000000 on 2026-09-17.
Files
| File | Type | Posted |
|---|---|---|
| P03 Sole Source Justification - 36C24E-26-AP-0578 - Neural Stem Cell Study.pdf | ||
| 36C24E26C0013_2.docx | DOCX document |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Limited / Sole Source Justification | |
| AN41--Research Services Neural Stem Cell Study for Spinal Cord Injury | Award Notice | |
| AN41--Research Services Neural Stem Cell Study for Spinal Cord Injury Pre-solicitation Notice with Intent to Sole Source | Special Notice | |
| AN41--Research Services Neural Stem Cell Study for Spinal Cord Injury Pre-solicitation Notice with Intent to Sole Source | Special Notice | |
| AN41--Research Services Neural Stem Cell Study for Spinal Cord Injury | Pre-Solicitation |
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