Post-Market Bioequivalence of Generic Drug Products

This solicitation seeks proposals to conduct post-market bioequivalence studies of generic drug products to establish therapeutic equivalence to branded reference products. The Department of Health and Human Services Food and Drug Administration will evaluate proposals to address specific scientific questions and quality concerns regarding generic drug products through clinical trials in healthy subjects or patients. Offerors must demonstrate the ability to design and conduct various study types, including bioequivalence, pharmacokinetic, or pharmacodynamic evaluations, in compliance with all applicable regulations and guidance. Proposals are due by February 29, 2024.

The single-award IDIQ contract has a maximum value of $20 million over five years to address bioequivalence studies on an indefinite basis. There is no set-aside designation. The place of performance is at sites selected by the contractor where studies will be conducted. The NAICS code is 541715 and PSC code is R425. Minimum personnel qualifications are specified for positions such as principal investigators, study coordinators, and bioanalytical scientists. The contract has a minimum guarantee of $2,000 per task order.