BioPharma Services USA Inc. has been awarded a 5-year, $20 million contract with the Food and Drug Administration to conduct studies of generic drugs in humans.
"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, CEO of BioPharma Services, Inc.
The FDA studies conducted by BioPharma will allow the Center for Drug Evaluation and Research, a division of the Food and Drug Administration, to proactively address scientific questions in developing generic approval standards and ensure post-market safety and efficacy of approved generic drug products. Ultimately, these studies will improve the generic review practice. As part of this contract, BioPharma will provide the FDA with a full-service offering, from study design and inception to clinical conduct, bioanalysis and final report.
Brent Matthews, COO at BioPharma Services Inc., said, "I am certain that our outstanding regulatory history with the FDA and our team’s extensive expertise in the conduct of bioequivalence trials played a major role in landing this important contract with the FDA.”