Lillian Ortega is the Owner and Chief Regulatory Strategist at WOW Solutions LLC, a consulting firm dedicated to guiding businesses through the complexities of FDA regulatory processes. With over a decade of distinguished service at the Food and Drug Administration, Lillian has extensive experience leading strategic and complex compliance and regulatory projects. Her expertise spans a broad range of sectors, including tobacco products, biologics, and FDA-regulated clinical research.

Before founding WOW Solutions, Lillian served as the Director of Enforcement and Manufacturing at the FDA’s Center for Tobacco Products. In this pivotal role, she led manufacturer compliance and enforcement programs, directed inspection activities, oversaw compliance actions, coordinated tobacco recall operations, and managed import activities. Lillian’s academic background in Microbiology and Public Health Policy complements her professional experience, enabling her to deliver invaluable insights to her clients.