Purchase Order 75F40123P00336
- Not listed
- 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 Environmental Protection Agency Office of Research and Development awarded a $12,390.00 firm-fixed-price purchase order to Certara UK LIMITED, doing business as Certara, a for-profit limited liability company. The contract is for the renewal of a software license for Certara's SIMCYP physiologically-based pharmacokinetic modeling software. Certara has previously provided this software to the Department of Health and Human Services Food and Drug Administration and the Environmental Protection...
- This is a firm fixed-price purchase order contract awarded by the National Institutes of Health (NIH) Clinical Center to Certara USA Inc., a leading provider of biosimulation software and consulting services. The contract, valued at $16,441.10, is for the procurement of software licenses for Certara's proprietary modeling and simulation tools, including Phoenix WinNonlin, Certara Phoenix, CHEMOFFICE, and SEND EXPLORER. These software products enable federal scientists and reviewers to conduct...
- The U.S. Food and Drug Administration (FDA) awarded a firm-fixed-price purchase order to Simulations Plus Inc., a for-profit software company specializing in pharmaceutical modeling and simulation. The contract, valued at $109,798.77, is for the purchase of 50 GastroPlus licenses, 30 IVIVCPlus module licenses, and 30 PBPK Plus licenses. The contract has no set-aside designation and is not associated with a larger contract vehicle. Simulations Plus has previously provided similar software...
- 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...
- This is a $375,965.05 firm-fixed-price purchase order awarded by the Food and Drug Administration (FDA) to Simulations Plus Inc. for GastroPlus, DDDPlus, and MembraneePlus software licenses. The contract has an ultimate completion date of August 31, 2026 and does not have a set-aside designation. Simulations Plus is a for-profit company that specializes in developing pharmaceutical modeling and simulation software, including tools for physiologically-based pharmacokinetic (PBPK) modeling, drug...
- This federal contract award to Certara USA Inc., doing business as Tripos (De), is for the provision of SEND Explorer Plus software licenses and annual maintenance services to the Food and Drug Administration (FDA), a civilian agency within the U.S. Department of Health and Human Services. The $129,832.56 firm fixed-price purchase order has a period of performance through September 29, 2025. Certara is a technology-enabled drug development and drug safety consultancy that specializes in...
- This is a $11,682 firm-fixed-price purchase order contract awarded by the National Institute on Drug Abuse, a civilian agency within the U.S. Department of Health and Human Services, to Certara USA Inc. The contract is for the licensing and subscription of Certara's proprietary biosimulation and data exploration software tools, including Phoenix WinNonlin, Certara Phoenix, CHEMOFFICE, and SEND EXPLORER. These software products enable federal scientists and reviewers at the National Institutes of...
- This is a firm-fixed-price purchase order awarded by the Food and Drug Administration (FDA) to Simulations Plus Inc., a small business for-profit software company, for the procurement of GastroPlus software licenses. The $252,421.24 contract provides the FDA access to Simulations Plus' physiologically-based pharmacokinetic (PBPK) modeling and simulation software, which supports research and regulatory decision-making in pharmaceutical development and assessment. The award does not appear to be...
- This $11,660 firm fixed-price purchase order contract was awarded to Certara USA Inc. by the National Institutes of Health (NIH) Clinical Center, a civilian agency. The contract is for the procurement of software licenses and subscriptions for Certara's proprietary modeling and simulation tools, which enable federal scientists and reviewers to conduct clinical pharmacology, pharmacometric, and regulatory review analyses on data submitted by industry sponsors. Certara USA Inc. is a leading global...
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 absorption, distribution, metabolism, and excretion processes in virtual patient populations, enabling optimization of drug development and supporting regulatory decision-making throughout the FDA's new drug approval processes. The FDA, particularly its Office of Clinical Pharmacology, utilizes SIMCYP software for reviewing investigational new drugs, new drug applications, biologics license applications, and abbreviated new drug applications. This procurement reflects the FDA's continued reliance on Certara's specialized modeling and simulation capabilities to reduce the need for clinical trials, accelerate drug development timelines, and improve drug efficacy and safety assessments. Certara has maintained a consistent vendor relationship with the FDA and other federal agencies since receiving its UEI in 2008, with previous federal contract awards demonstrating the critical role its PBPK technology plays in modern pharmaceutical regulatory science.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00002 | Exercise an Option | $162.8k | 8/27/25 | |
| P00001 | Exercise an Option | $155.0k | 5/14/24 | |
| Not listed | Not listed | $147.7k | 9/6/23 |