Raj Pai

Practice Areas

RAJ PAI is co-leader of the firm’s Food, Drug and Medical Device group. His practice focuses on representing life science companies in connection with Food and Drug Administration (FDA) regulatory compliance issues. Raj assists clients in advising on Quality systems issues and compliance, preparing for FDA inspections, addressing FDA observations from inspections, and developing strategies for addressing quality and regulatory compliance issues. Clients rely upon his advice while developing comprehensive action plans to address problems, preparing for meetings with FDA, and communicating and resolving complex regulatory questions with the agency in a collaborative manner. Raj also assists clients in FDA-related government investigations, enforcement proceedings, internal investigations, and litigation. These investigations and enforcement proceedings involve a range of matters, including marketing practices, product safety and reporting, good manufacturing practices (GMP), the Quality Systems regulation (QSR), data integrity, import issues, and civil and criminal violations of the Federal Food, Drug, and Cosmetic Act, as well as violations of the False Claims Act. His detailed understanding of complex and technical compliance issues allows him to understand the key facts and provide effective advocacy.

Prior to joining Sidley, Raj worked in the FDA’s Office of Chief Counsel. During his tenure, he worked closely with the FDA’s Office of Criminal Investigations, the Department of Justice and other federal agencies responsible for investigating, prosecuting and resolving criminal enforcement actions and related civil False Claims Act cases. Raj was appointed as a Special Assistant United States Attorney by the Department of Justice, and assisted in the indictment and successful prosecution of cases at both the federal and state level involving adulterated and misbranded foods, drugs, devices, dietary supplements, and cosmetics.