Purchase Order 75F40122P00491
- Not listed
- The U.S. Food and Drug Administration (FDA) awarded a firm fixed price purchase order to Certara UK Limited, doing business as Certara, a for-profit limited liability company, for SIMCYP software licenses and maintenance support. The $114,316.00 contract will allow the FDA's Office of Clinical Pharmacology Drug Reviewers to complete their review of investigational new drugs. Certara has previously provided this physiologically-based pharmacokinetic modeling software to the FDA and...
- The Food and Drug Administration awarded a $169.5K firm fixed-price purchase order to Certara USA Inc. for annual named user server licenses of Phoenix WinNonlin, Phoenix Connect, Phoenix NLME, and unlimited server license for distributed computing. The award was issued on July 30, 2019, with performance to be completed by July 29, 2022, at the contractor's facility in Silver Spring, Maryland. This contract was not set-aside and followed a solicitation posted on July 18, 2019, with award...
- The Food and Drug Administration awarded a firm fixed-price purchase order to Certara UK LIMITED (doing business as Certara) on September 6, 2023, for SIMCYP software licenses with a ceiling value of $815,948. The contract will be performed in Great Britain, United Kingdom, and is scheduled for ultimate completion by September 20, 2028. No set-aside designation was applied to this award. Certara provides physiologically-based pharmacokinetic (PBPK) modeling software that simulates drug...
- This is a $91,396 firm fixed-price purchase order issued by the Food and Drug Administration (FDA) to Certara USA Inc., doing business as Tripos (De), for the ratification of Phoenix Quantum licenses in fiscal year 2017. Certara is a technology-enabled drug development and drug safety consultancy that specializes in biosimulation and has received multiple federal contracts from the Department of Health and Human Services, including the FDA, National Institutes of Health, and Centers for...
- This is a firm fixed-price purchase order contract awarded by the Food and Drug Administration (FDA) to Pharsight Corporation, a subsidiary of Certara USA Inc. The contract, valued at $153,470.00, is for the provision of the "PHOENIX QUANTUM SOFTWARE BUNDLE" and is a total small business set-aside. The contract has a completion date of July 21, 2017. Certara USA Inc. is a leading global technology-enabled drug development and drug safety consultancy, specializing in biosimulation...
- The Food and Drug Administration (FDA) awarded a $65,451.84 firm fixed-price purchase order to Certara USA Inc. (doing business as Tripos (De)) for Phoenix Quantum licenses and support services. The contract was awarded on July 11, 2019, with an ultimate completion date of July 11, 2024, and was performed in Princeton, New Jersey. This contract reflects the FDA's ongoing reliance on Certara's pharmacokinetic and pharmacodynamic modeling software to support regulatory review activities and drug...
- The Department of Health and Human Services, Food and Drug Administration awarded a fixed-price purchase order contract to Certara USA Inc., doing business as Tripos (De), for an annual Phoenix Quantum software subscription. The contract, with a potential value of $216,547.78, provides the FDA's Office of Clinical Pharmacology with the necessary modeling and simulation tools to analyze and verify sponsor submissions, including Investigational New Drug, New Drug, Biologics Licensing, and...
- The Department of Health and Human Services' Food and Drug Administration awarded a $43,243.20 firm fixed price purchase order to Certara USA Inc. for SEND EXPLORER licenses. The place of performance is Silver Spring, Maryland. The one-year contract runs from September 12, 2023 through September 14, 2024. Certara USA Inc. will provide the FDA with software licenses to support the agency's regulatory science and public health protection missions. No subcontractors or set asides were identified....
- The federal contract award, valued at $10,743.00, was issued by the National Cancer Institute (NCI) to Certara USA Inc., a leading global technology-enabled drug development and drug safety consultancy, for the procurement of software licenses. The contract is a firm-fixed price purchase order with no set-aside designation and an ultimate completion date of August 13, 2025. Certara USA Inc. has received numerous prime contract awards from the NCI, Food and Drug Administration (FDA), and National...
- The U.S. Food and Drug Administration (FDA) awarded a $144,000.00 firm-fixed-price purchase order contract to Certara UK LIMITED, doing business as Certara, for the purchase of SIMCYP software. SIMCYP is a physiologically-based pharmacokinetic (PBPK) modeling software used to simulate drug absorption, distribution, metabolism, and excretion processes, which is crucial for optimizing drug development and facilitating regulatory reviews. This contract is not set aside for any specific business...
The U.S. Food and Drug Administration (FDA) awarded a Total Small Business set-aside purchase order to Certara USA Inc. for biopharmaceutical in vitro in vivo correlation and mechanistic modeling assessments software licenses. The contract, valued at $18,200, was awarded on September 19, 2022, with a completion date of September 20, 2023, and is structured as a firm fixed price purchase order. Performance of this work will occur in Calverton, Maryland. Certara USA Inc. is a leading biosimulation and drug development consultancy that provides specialized modeling and simulation software tools, including Phoenix WinNonlin and Certara Phoenix, which enable federal scientists and regulators to conduct clinical pharmacology and pharmacometric analyses supporting drug development and regulatory review. This award reflects the FDA's continued reliance on Certara's proprietary software solutions to support regulatory decision-making and scientific analysis within the agency's drug evaluation and review functions. As a established technology provider to the Department of Health and Human Services since 2007, Certara has developed an extensive track record of supporting federal health agencies including the National Institutes of Health, National Cancer Institute, and National Institute of Allergy and Infectious Diseases through similar software licensing and consulting arrangements. The firm fixed price structure and modest contract ceiling are consistent with Certara's typical purchase order awards to federal agencies for software subscriptions and licenses.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | Not listed | $18.2k | 9/18/22 |