Meet Our Legal Team
Managing Attorney & Principal
Jamie is considered by her peers to be a life sciences legal and regulatory compliance expert as she advises companies on a variety of U.S. Food and Drug Administration (FDA) regulatory, compliance, and enforcement issues. She also provides a broad range of business advice and strategic counseling to pharmaceutical, device and biologic manufacturers. Clients turn to Jamie for guidance in connection with audits, government investigations, internal investigations, contractual arrangements and the development, implementation and review of compliance and ethics programs. Notably, corporate executives and boards of directors also seek Jamie’s counsel on matters related to developing, implementing, evaluating, and auditing internal compliance and ethics programs. As part of her regulatory practice, Jamie advises on marketing authorization issues to post-marketing compliance, lifecycle management and significant enforcement matters. She also advises clients on product recalls, marketing applications, labeling, marketing and advertising permissibility, and privacy issues. Jamie also works with clients on post-marketing obligations such as adverse event reporting and Approved Risk Evaluation and Mitigation Strategies (REMS).
Small and Mid-sized life sciences companies turn to Brad as a trusted advisor. Brad advises companies on U.S. Food and Drug Administration (FDA) regulatory, compliance and enforcement issues. His practice is focused on developing practical solutions designed to allow small and mid-size life sciences companies achieve business objectives while at the same time minimizing legal risk and ensuring compliance with a variety of legal and regulatory obligations including but not limited to the Food, Drug and Cosmetic Act; the Prescription Drug Marketing Act of 1987 as amended; federal and state false claims acts; federal and state anti-kickback statutes; Foreign Corrupt Practices Act; Open Payments provisions of the PPACA; and the Lanham Act.
Alexandra advises a wide variety of clients in the life sciences sector. She assists clients with risk assessments, corporate and commercial compliance program development and implementation, internal investigations and industry operational strategies. She also advises on U.S. Food and Drug Administration (FDA) regulatory, compliance and enforcement issues.