Lillian Ortega

Background

About Lillian Ortega

With more than a decade of FDA regulatory experience, I am actively seeking consulting clients who can benefit from my in-depth expertise in compliance and regulatory issues related to biologics, medical devices and tobacco products. I have served in various leadership positions within the Center for Tobacco Products’ Office of Compliance and Enforcement and am the former director of the Division of Enforcement and Manufacturing where I planned and managed tobacco manufacturer inspection and surveillance programs, tobacco import operations, and enforcement programs. After leading many complex FDA projects, I have the experience and knowledge to help guide companies in resolving compliance and regulatory hurdles when navigating tobacco regulations and requirements. I’m also in an ideal position to help companies understand FDA regulatory processes and requirements so they can best position their products and manufacturing operations for success.