Epstein Becker Green provided a full spectrum of life sciences regulatory advice to a pre-commercial pharmaceutical company, including serving on the company’s medical legal review committee; advising on the conduct of late-stage clinical trials; helping the company with the development of a compliant patient support program; developing policies and procedures; negotiating contracts with contract research organizations, vendors, and other third parties; and counseling on compliance with FDA advertising and promotion restrictions, fraud and abuse laws, global privacy laws, and various others.
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