Post-Market Bioequivalence (BE) studies

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research is soliciting proposals for Post-Market Bioequivalence studies of generic drug products through an Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The procurement seeks a contractor to conduct comprehensive bioequivalence studies including Human Subject Research, pharmacokinetic studies, bioanalytical method development, clinical studies in healthy subjects or patients, quality characterization of drug products, and regulatory submissions to address scientific questions in developing generic approval standards and public concerns regarding generic drug quality. The contractor must provide key personnel including Project Managers, Contract Managers, Principal Investigators, Bioanalytical Scientists, and Study Coordinators, along with appropriate equipment and facilities for conducting these specialized studies. Proposals will be evaluated based on technical understanding and approach (most important factor), staffing plan and key personnel, equipment and facilities (equal importance), past performance, and price. Questions regarding this solicitation are due by 10:00am Eastern on August 13, 2025, with proposals due by 10:00am Eastern on August 21, 2025.

This procurement is classified under NAICS code 541715 with a small business size standard of $16.5 million and carries no set-aside designation, making it available to all qualified contractors. The contract has a guaranteed minimum value of $2,500 and a maximum estimated value of $20 million over a five-year ordering period spanning from September 30, 2025 to September 29, 2030. The solicitation includes ten distinct labor categories ranging from Project Managers and Application Developers to specialized positions such as Pharmacists and Scientists, including visa-eligible positions for certain categories. Task orders under this IDIQ contract will utilize various contract types including firm-fixed-price, labor hour, and time-and-materials arrangements. The pricing worksheet accommodates multiple ordering periods across the five-year performance timeline, indicating the government's expectation for ongoing bioequivalence study requirements throughout the contract duration.