Purchase Order 75F40120P00551
- 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 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 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...
- 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...
- This federal contract awarded by the Department of Health and Human Services (HHS) Food and Drug Administration (FDA) to Certara USA Inc., doing business as Tripos (DE), is for $83,806.57 to provide Certara Phoenix software licenses for pharmacokinetic modeling and simulation. The contract is a firm fixed-price purchase order with a completion date of August 31, 2026. Certara is a technology-enabled drug development and drug safety consultancy that has received numerous prior federal contract...
- 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 $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...
- 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 firm-fixed price purchase order contract was awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to Certara UK LIMITED, doing business as Certara, a for-profit limited liability company. The $164,400 contract provides annual licenses and maintenance support for Certara's SIMCYP physiologically-based pharmacokinetic modeling software. The software is used by the FDA's Office of Clinical Pharmacology to review submissions from pharmaceutical sponsors, such as INDs, NDAs, BLAs, and ANDAs. This was an unrestricted procurement with no set-aside designation. Certara has previously received FDA grant funding to support the development of modeling capabilities related to topical drug products and virtual bioequivalence assessments.
Name | Description | Solicitation Number | FederalAgency | Type | PostedDate |
|---|---|---|---|---|---|
CERTARA SIMCYP Licenses Subscription (Brand Name or Equal) | FDA-RFQ-20-1226258 | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Solicitation 1/1 | 8/10/20, 8:18 PM |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00001 | Exercise an Option | $83.8k | 9/16/21 | |
| Not listed | Not listed | $80.6k | 8/26/20 |