Purchase Order 75F40121P00220

The Department of Health and Human Services Food and Drug Administration (FDA) awarded a firm-fixed price purchase order contract to Icon Clinical Research LLC, a foreign-owned for-profit organization, for the CDER SOFTWARE LICENSE RENEWAL FOR ICON NONMEM FY22. The contract, with a potential value of $10,900.00, provides software licenses and renewals for the NONMEM (Nonlinear Mixed Effects Modeling) software, which is used by FDA clinical pharmacology reviewers and pharmacometricians. This...

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...

This is a firm-fixed-price purchase order 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 $815,948.00 contract is for Certara's SIMCYP software licenses, which provide physiologically-based pharmacokinetic (PBPK) modeling capabilities to facilitate regulatory decision-making and optimize drug development. The SIMCYP software is used by the FDA's Office of...

This sole source contract awarded by the Department of Health and Human Services' National Institutes of Health National Institute on Drug Abuse to Chemaxon LLC is for annual license renewals of JChem Oracle Cartridge and Marvin JS software. Valued at $10,490, the firm fixed price contract provides 100 user licenses for both the JChem Oracle Cartridge and Marvin JS Library from July 1, 2023 through June 30, 2024 with an additional four 12-month option periods. The software licenses are...

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 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 firm-fixed-price purchase order awards Simulations Plus Inc., doing business as Simulations Plus, a contract valued at $375,965.05 to provide software licenses for GastroPlus, DDDPlus, and MembranePlus to the Food and Drug Administration (FDA). These software products are used for physiologically-based pharmacokinetic (PBPK) modeling, predicting drug absorption and pharmacokinetics, and conducting virtual bioequivalence studies to support pharmaceutical research, development, and regulatory...

The Department of Health and Human Services National Institutes of Health National Institute of Allergy and Infectious Diseases awarded a firm fixed price purchase order to DXC Technology Company for $57,351.36. The contract is for the procurement of DXC Toolbox Pharma Edition software licenses and annual maintenance to replace expiring verification software and enable continued review of electronic submissions to the FDA for investigational new drugs and drug master files. Specifically, DXC...

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...