Certara Phoenix License Subscription Renewal
Closed Solicitation Posted
A later notice was posted: the Limited / Sole Source Justification 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
- 11 Agriculture, Forestry, Fishing and Hunting
- Place of performance
- United States
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Food and Drug Administration (FDA) seeks to renew existing Certara Phoenix software license subscriptions to support the evaluation of clinical pharmacology and pharmacometric data submitted to the agency. The objective is for FDA reviewers to access Certara Phoenix licenses to complete the review of abbreviated new drug applications and other regulatory activities. Quotes for the firm-fixed price purchase order are due by July 14, 2023 for a one-year subscription period beginning July 1, 2023.
There is no set-aside designated for this requirement. The incumbent contractor is Certara USA, Inc., the developer of the Phoenix software. The place of performance will be within the United States. FDA intends to award a sole source contract to Certara USA, Inc. based on the justification that FDA receives submissions using Phoenix and requires access to the same software to evaluate the data.
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.
Files
| File | Type | Posted |
|---|---|---|
| JOFOC.pdf | ||
| Formal RFQ (75F40123Q00316).pdf |
Notice history
| Notice | Type | Posted |
|---|---|---|
| JOFOC for Certara Phoenix Licenses | Limited / Sole Source Justification | |
| This notice | Solicitation | |
| Notice of Intent for Sole Source - Certara Phoenix License Renewal | Special Notice |
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