Kenneth L. Berger, Ph.D.

Director of Regulatory Affairs

Kenneth L. Berger, Ph.D., has over 30 years of experience in the pharmaceutical, biologics, and medical device industries, with 17 years of regulatory and quality management experience. Prior to joining CSC, Dr. Berger held numerous senior QA/RA positions in FDA regulated industry including Irvine Pharmaceutical Services (Irvine CA), cGMP Validation (West Coast), LifePoint (Ontario, CA), Techniclone (Irvine, CA), and Synbiotics, (San Diego, CA), and also held key R&D positions at VLI (Irvine, CA), American McGaw (Irvine, CA), and Syntex Research (Palo Alto, Ca). He brings with him a comprehensive understanding of new product development and product efficacy evaluations, cGMP regulation and global cGMP harmonized guidance, and is trained in all aspects of Quality System compliance. Dr. Berger has a Ph.D. in Biochemistry from the University of Southern California, Los Angeles.