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 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,...
This federal contract award is for a software upgrade and annual maintenance services for the FDA's SEND Explorer Warehouse system. The contract was awarded by the Department of Health and Human Services' Food and Drug Administration (FDA) to the prime contractor Integrated Nonclinical Development Solutions Inc. (IND Solutions), a technology-enabled drug development and drug safety consultancy. The contract has a potential value of $257,000.00 and does not use a set-aside designation. The...
This is a firm-fixed price purchase order contract awarded by the Food and Drug Administration (FDA) to Certara USA Inc., a leading global technology-enabled drug development and drug safety consultancy. The $845,852.26 contract is for the procurement of Certara's Phoenix software licenses, subscriptions, and specialized consulting services to support the FDA's drug review and evaluation processes. Specifically, the software tools, including Phoenix WinNonlin, Certara Phoenix, CHEMOFFICE, and...
The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a firm-fixed-price purchase order contract to Integrated Nonclinical Development Solutions Inc. (IND Solutions), a small business, for FY20 Annual SEND Explorer Warehouse and Technical Support. The contract has a potential value of $179,000.00 and a period of performance from August 1, 2020 to July 31, 2021. This contract was awarded under a total small business set-aside. IND Solutions, a...
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 is a $169,504.71 firm-fixed price purchase order awarded by the U.S. Department of Health and Human Services (HHS) Food and Drug Administration (FDA) to Certara USA Inc., doing business as Tripos (DE), a technology-enabled drug development and drug safety consultancy. The contract provides annual named user server licenses for Certara's Phoenix WinNonlin, Phoenix Connect, Phoenix NLME software, as well as an unlimited server license for distributed computing. This supports the FDA's...
The Department of Health and Human Services' Food and Drug Administration awarded a $157,134 firm fixed price delivery order contract to Regan Technologies Corporation. This order is placed against Solutions for Enterprise-Wide Procurement V, a government-wide acquisition contract vehicle, to provide CLC BIO software licenses. The place of performance is Silver Spring, Maryland. The one-year contract begins on September 27, 2023 and concludes on September 29, 2024. As the FDA works to protect...
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...
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...