Douglas W. Balogh, Ph.D., is a director in Guidehouse's  Life Sciences Disputes, Regulatory, Compliance, and Investigations (HLS DRCI) practice, focusing on FDA regulatory matters.

Balogh has more than 31 years of industry experience in drug product development and regulatory affairs. Prior to joining Guidehouse, Doug's extensive experience at Eli Lilly and Company has included numerous scientific and managerial leadership positions in the Research and Development organization.

At Guidehouse, Balough's strong technical background is a cornerstone of his service to clients as a pharmaceutical regulatory affairs specialist. He has assisted clients in development of regulatory strategies, development of CMC strategies, achieving successful INDs, obtaining orphan drug designations, submitting 505(b)(2) applications, and guided clients through successful meetings with FDA.