Camargo Pharmaceutical Services, a full-service clinical research organization (CRO) specializing in the continuum of drug development, is honored to receive the 2009 Regulatory Sciences Section Outstanding Contributed Paper award for their poster titled "CMC for 505(b)(2) Applications." The poster was presented by Camargo's President and CEO, Ken Phelps, and Vice President of Chemistry, Manufacturing and Control (CMC) Services, Lynn Gold, Ph.D., on Tuesday, November 10, 2009, at the 2009 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition.

Camargo's poster presentation focused on the importance of the CMC Section of any application to the FDA and how this data serves as the cornerstone for demonstrating the quality of the drug product. The presentation also outlined variations that can occur from application to application depending on the dosage form, drug product and type of file under construction, specifically as it relates to a 505(b)(2) application.

"Camargo is focused on end-to-end drug development through the 505(b)(2) pathway; it is an incredible honor to be recognized in the CMC arena. A comprehensive, cohesive drug development plan that takes into consideration all pivotal points in the spectrum is vital to a successful filing. The AAPS scientific poster sessions are an excellent mechanism to discuss and present our most current research," stated Dr. Gold. Camargo's poster was chosen as one of three award winners within the Regulatory Section, with a total of 29 posters reviewed.

About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is a full-service CRO for the continuum of drug development. With more than 150 FDA approvals, Camargo works with companies to develop comprehensive programs, managing every facet of the plan from formulation and testing the drug product, conducting clinical studies and FDA application submissions. For more information visit www.camargopharma.com.

SOURCE: Camargo Pharmaceutical Service