ARIF NOORANI is a partner in Sidley’s Food, Drug and Medical Device Compliance and Enforcement group.
Arif helps life sciences companies navigate U.S. Food and Drug Administration (FDA) compliance requirements in the United States and around the world covering multiple product portfolios (pharmaceuticals, medical devices, biologics and vaccines, and combination products). He guides clients through a range of matters related to good manufacturing practices (cGMP/QSR), good distribution and storage practices, clinical trials, data integrity investigations, pharmacovigilance, and product quality and safety reporting obligations. Arif prepares his clients for FDA inspections to identify risks early and builds corrective and remediation action plans to achieve sustainable compliance. Arif frequently leads internal reviews to assess whistleblower complaints and potential compliance violations, and defends companies during FDA and U.S. Department of Justice (DOJ) investigations and enforcement actions. He provides strategic counseling that helps resolve inspection observations, warning letters, import alerts, and consent decrees.