BioPharma Services USA has been awarded a 5-year, $20 million contract with the Center for Drug Evaluation and Research (CDER), a division of the US Food and Drug Administration (FDA). The contract is to conduct in vivo studies of generic drug products in human subjects over a period of five years, from 2016 through to 2021.

“We are very proud to work with the FDA in support of their generic drug programs. This award is a great example of BioPharma’s capabilities as a leading industry expert in bioequivalence and early stage clinical research,” said Renzo DiCarlo, chief executive officer, BioPharma Services.

The FDA studies conducted by BioPharma will allow CDER to address scientific questions in developing generic approval standards and ensure post-market safety and efficacy of approved generic drug products. Ultimately, the goal of these studies is to help improve the generic review practice within CDER. As part of this contract, BioPharma will provide the FDA with a full service offering from study design inception to clinical conduct, bioanalysis and final report.