Tamra guides medical device manufacturers, hospital systems, and pharmaceutical companies through operational and regulatory compliance assessments. Utilizing regulatory knowledge, complex data analyses, and a keen understanding of specific business operations and risk management needs, Tamra advises on health care compliance programs, FDA compliance matters, enforcement actions, internal investigations, and defense of external government investigations.
Tamra regularly represents clients in government investigations involving the False Claims Act, Anti-Kickback Statute, and Stark Law. She is experienced in proceedings and litigation at the administrative, state, and federal levels, as well as responding to FDA enforcement actions. Tamra’s product and system knowledge directs her advocacy efforts, with a particular focus on reconciling newly emerging technology with existing regulatory requirements and guidance. Drawing from her experience in crisis management and creating operational alignment, Tamra remains focused on reducing interruption, allowing her clients to continue providing innovative and critical health care services nationwide and abroad.
Tamra’s extended legal background includes volunteering at Nicaragua’s Human Rights Commission and working with state legislators to combat human trafficking.
