Notice of Intent for Sole Source - Certara Phoenix License Renewal
Closed Special Notice Posted
Not the latest version. See the latest solicitation from .
- Solicitation number
- 75F40123Q00316
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 513210 Software Publishers
- Place of performance
- Beltsville, Maryland 20705, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration's Office of Acquisitions and Grants Services published this Notice of Intent to sole source the renewal of hundreds of Certara USA Inc.'s Phoenix Quantum software licenses and IVIVC Toolkits. The software tools are essential for the Office of Clinical Pharmacology's drug reviewers and pharmacometricians to analyze clinical pharmacology and pharmacometric data submitted by sponsors in various applications on strict timelines.
This Special Notice intends to sole source the acquisition from Certara USA Inc. located in Princeton, New Jersey, using FAR 6.302-1(b)(1)(i) as the software tools are unique and only available from the single source supplier. Interested parties have 15 days from issuance to submit an alternative quote, though the determination to open the requirement remains at the Government's discretion. The software licenses and toolkits provide necessary Phoenix WinNonlin, NLME, IVIVC, Connect, and Trial Simulator capabilities for reviewers to independently analyze sponsors' submissions to the Investigational New Drug, New Drug Application, Biologics Licensing Application, and Abbreviated New Drug Application processes and ensure public health impacts are met.
Notice text
The Office of Acquisitions and Grants Services (OAGS) intends to sole source using the authority of FAR 6.302-1(b)(1)(i), unique supplies or services available from only one source or only one supplier with unique capabilities. Only the prospective contractor, CERTARA USA INC. (located at 100 Overlook Ctr., Ste 101, Princeton, NJ 08540), can provide software (i.e. Phoenix Quantum) to allow Office of Clinical Pharmacology drug reviewers to complete the review of INDs, NDAs, BLAs, ANDAs, and other submissions from sponsors, the primary role of the Office
Files
| File | Type | Posted |
|---|---|---|
| Notice of Intent to Sole Source.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| JOFOC for Certara Phoenix Licenses | Limited / Sole Source Justification | |
| Certara Phoenix License Subscription Renewal | Solicitation | |
| This notice | Special Notice |
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