ARIF NOORANI is a partner in Sidley’s Food, Drug and Medical Device Compliance and Enforcement group.
Arif brings a wealth of knowledge in helping his clients navigate the complex world of pharmaceutical and medical device compliance in the United States and abroad. His practice focuses on life sciences companies in regulatory, civil, and criminal matters covering a range of product portfolios (e.g., drugs, devices, biologics, combination products) in connection with the Federal Food, Drug, and Cosmetic Act (FDCA), the False Claims Act (FCA), and other fraud and abuse provisions. Arif regularly advises senior executives and provides strategic counseling on product development, quality and manufacturing compliance (cGMP/QSR), post-marketing safety reporting, supplier management and supply chain security, and regulatory inspections. He has led numerous internal investigations involving allegations of FDCA violations and has defended clients in related government proceedings and subsequent FCA litigation. In addition, Arif often counsels clients on developing risk-based oversight and compliance systems following U.S. Food and Drug Administration (FDA) and U.S. Department of Justice (DOJ) actions, including the issuance of 483 observations, warning letters, civil investigative demands, subpoenas, and consent decrees.