Practice Areas
Cori is a partner in Reed Smith’s Life Sciences Health Industry Group. She focuses her practice on FDA regulatory issues for the food, drug, dietary supplement, biologic, medical device, and HCT/P industries across the supply chain, including companies investing in these industries.
Cori advises her food law clients on FDA and USDA issues, including labeling analysis, FSMA implementation, importation issues, food safety, and corporate compliance concerns. She assists clients during FDA inspections, in responding to FDA 483s, and with recalls and market withdrawals of products. Her practice includes the provision of regulatory assistance during corporate transactions involving food companies. She also represents large corporations in investigations by the U.S. Department of Justice, the U.S. Food and Drug Administration, and other federal and state agencies.
In addition, Cori provides legal and strategic advice to life sciences and health care clients regarding communications with FDA; pre-submission meeting requests and product approval submissions to FDA; product labeling, advertising, and promotion; clinical research considerations across the product life cycle; and corporate compliance concerns. She assists clients during FDA inspections and with product recalls, and also represents clients during internal investigations and self-disclosures to the FDA, Department of Justice, and other federal and state agencies.
Cori also advises product manufacturers, distributors, and retailers on regulatory compliance surrounding CBD products.
On the transactional side, Cori routinely advises strategic owners, private equity funds, underwriters and other public and privately-held businesses seeking specialized FDA support in connection with health care and life sciences financing and securities transactions, and domestic and international mergers and acquisitions.
