Arif Noorani

Partner at Sidley Austin LLP

Speaker

ARIF NOORANI 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), clinical trials, data integrity investigations, pharmacovigilance, good distribution and storage practices, and product quality and safety reporting obligations. Arif prepares his clients for FDA inspections to identify risks early and builds business minded corrective and preventive 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. Arif also counsels clients engaged in corporate life sciences transactions, including negotiating representations and warranties for FDA-related diligence.