Post-Market Bioequivalence (BE) Studies

The FDA Office of Acquisition and Grant Services is procuring post-market bioequivalence (BE) studies through an Indefinite Delivery/Indefinite Quantity (IDIQ) contract focused on evaluating generic oral drug products when co-administered with acid-reducing agents. This solicitation (FDAFO121683) represents a reissuance of a previous RFP with minimal changes and seeks comprehensive clinical research services including study protocol development, bioanalytical method validation, clinical trial conduct, and statistical analysis. The contract requires specialized labor categories including Project Managers with clinical trial experience, Bioanalytical Scientists, Principal Investigators with advanced medical degrees, and Study Coordinators, all requiring significant experience in Phase I clinical trials and bioequivalence studies. Technical evaluation will assess the proposed approach to conducting these studies, past performance in similar clinical research, and pricing across multiple ordering periods. The response deadline has been extended to September 28, 2025, at 12:00 PM EST, with all other terms and conditions remaining unchanged from the original solicitation.

This opportunity was originally designated as an 8(a) set-aside but was converted to full and open competition on April 30, 2025, after no capable 8(a) proposals met the technical requirements. The sample task order involves a 36-month performance period with a specific clinical trial design utilizing 50 adult healthy volunteers across four treatment periods under fasting conditions. The study will employ SmartPill technology to monitor gastrointestinal tract conditions and compare pharmacokinetic endpoints between reference listed drugs and generic drug products. Key personnel requirements span five ordering periods and include various scientific roles with both standard and visa-specific variants, suggesting potential international collaboration. The contract aims to help FDA establish regulatory standards for generic oral products with pH-sensitive formulations, with the first 6-7 months dedicated to startup activities including protocol development and IRB approvals.