JOFOC for Certara Phoenix Licenses
Awarded Limited / Sole Source Justification Posted
- Solicitation number
- 75F40123Q00316
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75F40123P00234 Federal contract award
- Awardee
- Certara USA Inc.
- NAICS code
- 541519 Other Computer Related Services
- Place of performance
- United States
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Food and Drug Administration published a Limited/Sole Source Justification Notice on July 19, 2023 to award a sole source contract to Certara USA, Inc. for annual Phoenix Quantum software licenses. The FDA requires Phoenix Quantum to perform pharmacometrics reviews and analyses of clinical pharmacology and pharmacometrics data submitted in drug, biologics, veterinary medicines, and tobacco product applications to ensure safety and efficacy. Phoenix Quantum is cited as the only software that meets the FDA's requirements for such analyses. The contract was awarded to Certara USA, Inc. for an unknown quantity and value to provide Phoenix Quantum licenses and maintenance to allow FDA reviewers to complete regulatory duties.
Notice text
The objective is to obtain the annual Phoenix Quantum software licenses to allow OGD reviewers to complete the
review of ANDAs and well as other regulatory activities, such as pre-ANDA meeting package review and
production of product-specific bioequivalence guidance.
Awarded contract 75F40123P00234 to unknown vendor for unknown amount on 2023-07-19.
Files
| File | Type | Posted |
|---|---|---|
| JOFOC.pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| This notice | Limited / Sole Source Justification | |
| Certara Phoenix License Subscription Renewal | Solicitation | |
| Notice of Intent for Sole Source - Certara Phoenix License Renewal | Special Notice |
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity