Definitive Contract 75F40126C00071
- Not listed
- The U.S. Food and Drug Administration (FDA) awarded a $515,769.89 firm fixed price definitive contract to the University of St. Gallen, a Swiss educational institution, to conduct research and develop tools to strengthen post-market surveillance of FDA-regulated products. The objective is to apply advanced analytics and hybrid artificial intelligence to improve risk identification. This contract was awarded under the FDA's Fiscal Year 2025 Broad Agency Announcement (BAA) for Advanced Research...
- The U.S. Food and Drug Administration (FDA) awarded a $1,155,442.55 Cost Plus Fixed Fee contract to Cubrc, Inc. to conduct research and development on the "Immunogenicity Risk of Peptide Drug Generics and Their Impurities: In Silico and In Vitro Assessment and Validation Methods." The contract, which has a period of performance ending September 27, 2022, was issued under the FDA's Broad Agency Announcement (BAA) solicitation for advanced research and development to support regulatory...
- The Food and Drug Administration (FDA) awarded a $527,318.00 definitive contract to Uppsala Universitet, a Swedish educational institution, to conduct research and development on model-integrated strategies for bioequivalence evaluation of drugs with high variability and/or long half-life. This contract was awarded under the FDA's Broad Agency Announcement, which seeks proposals to advance regulatory science in various areas. The contract has no set-aside designation and is intended to support...
- The Food and Drug Administration awarded a $964,769 definitive contract to Rutgers, The State University on September 29, 2023, for research on the role of excipients and excipient substitution in topical semi-solid formulations and their effect on product performance and quality. The contract stems from an FDA Broad Agency Announcement posted November 14, 2022, soliciting advanced research and development proposals across regulatory science and innovation. Rutgers' Research Financial Services...
- The U.S. Food and Drug Administration (FDA) awarded a Total Small Business set-aside purchase order to Certara USA Inc. for biopharmaceutical in vitro in vivo correlation and mechanistic modeling assessments software licenses. The contract, valued at $18,200, was awarded on September 19, 2022, with a completion date of September 20, 2023, and is structured as a firm fixed price purchase order. Performance of this work will occur in Calverton, Maryland. Certara USA Inc. is a leading biosimulation...
- The Food and Drug Administration awarded a $325,000 definitive contract to Institute For Clinical Pharmacodynamics, Inc. on August 1, 2026, for development of susceptibility guidance for daptomycin and enterococcus species using pharmacometric approaches under the FY26 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science. Place of performance is Schenectady, NY. The contract runs through July 31, 2027, under firm fixed price terms with no set-aside. The...
- The U.S. Food and Drug Administration (FDA) awarded a $3,090,714.59 definitive cost no fee contract to DNA Hive LLC, a small disadvantaged business, to develop a next generation medical countermeasures scientific platform for regulatory evaluation and preparedness under Broad Agency Announcement (BAA) #FY25C3AP3. The contract has an ultimate completion date of September 29, 2028 and was awarded on September 23, 2025. The FDA BAA solicits basic and applied research and development proposals to...
- The Food and Drug Administration awarded a $1.0M firm fixed-price contract to Ita-Suomen Yliopisto (University of Eastern Finland) on September 29, 2023, to conduct research on understanding preservative effects on bioequivalence of topical ocular products. The contract, which extends through November 30, 2026, was awarded under the FDA's Broad Agency Announcement for Advanced Research and Development of Regulatory Science. This research effort supports the FDA's mission to modernize product...
- The U.S. Food and Drug Administration (FDA) awarded a $901,888.19 definitive contract to the National Academy of Sciences (NAS), a non-profit organization, to produce a consensus report that identifies innovative technologies to advance pharmaceutical manufacturing. The contract, which is not set aside, was awarded on July 19, 2019 with a completion date of March 31, 2022. The report will assist the FDA's Center for Drug Evaluation and Research (CDER) in fostering the adoption of innovative...
- Landrau Scientific Innovations LLC was awarded a $567,980 firm fixed price definitive contract by the Department of Health and Human Services Food and Drug Administration to support the agency's Broad Agency Announcement PMQWP#237. This BAA seeks advanced research and development proposals to evaluate critical process parameters for the preparation of amphotericin B that influence toxicity, advancing the FDA's regulatory science and innovation goals. The prime contractor will conduct work at its...
The Food and Drug Administration awarded a $1,083,957 definitive contract to Certara UK LIMITED on September 30, 2026, for advancing integration of in vitro topical product characterization and skin permeation data. The award stems from the FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science, posted November 21, 2025, with due date of February 24, 2026. The BAA seeks basic and applied research and development proposals to support regulatory science innovation across FDA-regulated domains, with a focus on modernizing development and evaluation of FDA-regulated products. The solicitation operates under FAR 6.102(d)(2) and 35.016 and was classified under NAICS 541714 (Research and Development in Biotechnology) and PSC code AJ11 (General Science and Technology R&D Services). Place of performance is Great Britain, United Kingdom. The contract is firm fixed price with an ultimate completion date of September 29, 2029. No set-aside was used.
Name | Description | Solicitation Number | FederalAgency | Type | PostedDate |
|---|---|---|---|---|---|
FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | FDABAA-26-00123 | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Special Notice 1/1 | 11/21/25, 8:57 AM |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | Not listed | $353.0k | 9/9/26 |