The Department of Health and Human Services Food and Drug Administration awarded a Firm Fixed Price contract to Pointcross, Inc., a for-profit corporation, for a Risk Modeling and Simulation Tool (RMST) software platform license maintenance, upgrades, and support services. The contract has a potential value of $719,217.00 and a completion date of August 16, 2020. The award was made on a sole-source basis as a follow-on to an existing contract, with no set-aside designation. Pointcross also holds...
The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a $1,424,274.00 Firm Fixed Price Delivery Order contract to Pointcross, Inc., a for-profit organization, for CTP Risk Modeling and Simulation Tool Support Services. The contract does not have a set-aside designation. Pointcross, Inc. is providing software platform license maintenance, upgrades, and support services for the agency's Risk Modeling and Simulation Tool over two consecutive 5-year periods....
The Department of Health and Human Services Food and Drug Administration awarded a definitive contract valued at $8.5 million to Pointcross, Inc. of Silver Spring, Maryland. The contract is for Risk Modeling and Simulation Tool software platform license maintenance, upgrades, and support over a five-year period. Pointcross will provide ongoing operations, maintenance, and training for the agency's Risk Modeling and Simulation Tool, which toxicologists use to review nonclinical study data. The...
The U.S. Food and Drug Administration (FDA) awarded a $1,000,060.00 firm fixed-price delivery order contract to Pointcross, Inc., a small business located in Foster City, California. The contract is for risk modeling and simulation tool software platform license maintenance, upgrades, and support services over a period ending on September 15, 2016. This is a follow-on award to an existing contract, with no set-aside designation. Pointcross also holds a $500,000 Multiple Award Schedule contract...
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,...
The Department of Health and Human Services Food and Drug Administration awarded a two-year, firm fixed price purchase order valued at twenty thousand seven hundred forty dollars and twenty-five cents to Vprime TECH Inc. to fulfill a solicitation for JRebel and XRebel software licenses. Per the solicitation, the Center for Tobacco Products requires the specified software to support its regulatory activities. The place of performance will be in Houston, Texas. No set aside designation or...
This definitive, firm fixed-price contract was awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to CFD Research Corporation, a for-profit organization, to develop a multiscale computational framework for assessing the bioequivalence of orally inhaled drugs. The $499,761 contract does not have a set-aside designation. The original solicitation was a Broad Agency Announcement (BAA) seeking research and development to advance FDA's mission of protecting...
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, 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 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...