Quintiles Transnational, an international contract research organization, has created a biologics regulatory team to offer customers consulting services about regulatory issues.

The group will focus on submissions dealing with vaccines, monoclonal antibodies, stem- cell based therapies and other products.

The team was formed due to requests from companies for assistance and expertise in biologics.

Ed Tabor, head of Regulatory Affairs, Americas, and Beatrice Deprez, head of Regulatory Affairs, Europe and International, will lead the effort.

"Over the past several years, biologics have acquired an increasing share of new product development in the pharmaceutical and biotechnology industries," Tabor said in a statement. "The experts in this new Quintiles Regulatory unit understand the major and minor differences between what regulatory authorities expect for the successful development of drugs and what is expected for biologics. Successful biologics development begins with good planning, and that starts with a clear understanding of the regulatory landscape."

The team includes eight people.

Tabor is a former FDA division director in both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). He also served as associate director for Biological Carcinogenesis at the National Cancer Institute. Deprez has more than 25 years of regulatory experience in Europe.