BioPharma Services USA has been awarded a five-year, $20 million contract with the Center for Drug Evaluation and Research (CDER), a division of the 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, CEO at BioPharma Services, Inc.
The FDA studies conducted by BioPharma will allow CDER to proactively address scientific questions in developing generic approval standards and ensure post-market safety and efficacy of approved generic drug products. Ultimately, the outcome of these studies will 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.
Brent Matthews, COO at BioPharma Services, 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.”