Lillian Ortega has over a decade of expertise in leading strategic and complex compliance and regulatory projects at the Food and Drug Administration. Her deep-rooted experience in FDAr egulatory processes is not just extensive but current. Ortega’s specialization encompasses a broad range of sectors, including tobacco products, biologics, and FDA-regulated clinical research.

Ortega’s understanding of FDA regulatory processes and requirements for tobacco products is based on firsthand experience. Before becoming a regulatory consultant, she held the pivotal role of director of enforcement and manufacturing at the FDA’s Center for Tobacco Products. This position entrusted her with a breadth of responsibilities, including leading manufacturer compliance and enforcement programs, directing inspection activities, overseeing compliance actions, coordinating tobacco recall operations, and managing import activities. Ortega’s academic foundation is in microbiology and public health policy.

Ortega’s unique blend of experience, both in regulatory oversight and in guiding businesses, enables her to provide invaluable insights. She empowers organizations to not only comprehend but also adeptly navigate the maze of FDA regulatory processes. Her consulting services are designed to position products and operations for optimal success in a highly regulated landscape.‍