BAA contract- FY26C2DP2-beyond compliance: integrating quality culture and risk in pharmaceutical quality management
Active Definitive Contract Awarded Last action
- Contract number
- 75F40126C00070
- Awardee
-
Universitat ST. Gallen UEI LLK6D5M1UAF1
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $435,179
Award facts
- Opportunity
-
- FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Special Notice · FDABAA2600123 · Posted Nov 21, 2025
- Contract value 100% obligated
- $435,178.88 Current and potential, with all options
- Completion date 5% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 611310 Colleges, Universities, and Professional Schools
- PSC
- AJ11 General Science And Technology R&D Services; General Science And Technology; Basic Research
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Negotiated Proposal / Quote
- Pricing
- Firm Fixed Price
- Place of performance
- Silver Spring, MD 20993, USA
- Legislative mandates
-
- Service Contract Inventory FAR subpart 4.17
Award details come from SAM.gov/FPDS.
About this award
The Food and Drug Administration awarded a $435,178.88 definitive contract to Universitat ST. Gallen on September 30, 2026, for advanced research and development in regulatory science under the FY26 FDA Broad Agency Announcement, with no set-aside applied.
The originating BAA solicitation, posted November 21, 2025, seeks basic and applied research to advance scientific knowledge in regulatory science and innovation aligned with FDA's mission. Research priority areas include modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. The BAA invites extramural research from eligible organizations, including academic institutions, under FAR 6.102(d)(2) and 35.016. The opportunity is classified under NAICS 541714 (Research and Development in Biotechnology) and PSC code AJ11 (General Science and Technology R&D Services).
Place of performance is Silver Spring, MD 20993. The contract period runs through September 29, 2027. Pricing is firm fixed-price. The contract represents a continuation of the university's engagement with the FDA on regulatory science initiatives, with prior awards totaling approximately $2.186 million between 2021 and 2025 on related research topics.
Quick answers
Who was awarded contract 75F40126C00070?
75F40126C00070 was awarded to Universitat ST. Gallen by Food and Drug Administration (Department of Health and Human Services) on September 30, 2026.
How much is contract 75F40126C00070 worth?
The government has obligated $435,179 on 75F40126C00070.
Was contract 75F40126C00070 competed?
The extent of competition for 75F40126C00070 was full and open competition. The government received 1 offer.
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