Our Expertise
Represent and counsel domestic and international pharmaceutical, bulk pharmaceutical (API), medical device and biotech companies, both established and startup, brand-name and generic, in all aspects of FDA regulation, corporate practice and compliance, litigation, and allied commercial transactions. Also serve on boards of directors of companies in the pharmaceutical and FDA consulting fields
Marketing & Advertising
Serve on promotional review committees (PRC) of pharma and medical device companies; review and approve advertising, marketing campaigns, grants, educational activities. Develop corporate structures for review and compliance
Pharmaceutical
Advise on regulation of pharmaceuticals including brand name, generic, OTC, including requirements for approval (NDA; ANDA), product labeling, websites; cGMP compliance; FDA enforcement actions; Application Integrity Policy; pharmacy compounding
Education & Training
Teach courses to industry internationally on Advertising and Promotion Regulation and Practices; conduct training for company executives and sales representatives on advertising and marketing compliance; responding to FDA enforcement actions; contract negotiation and drafting
Medical Devices
Develop and draft 510K applications to FDA. Received approvals for devices including for cardiovascular, dental, electro-stimulation (TENS), wound-healing. Develop strategies for device approvals
Commercial
Negotiate and advise on agreements for commercial pharmaceutical and medical device supply, product licensing, joint venture, transfer of drug applications and medical device registrations
Administrative & Litigation
FDA; FTC, DEA, CPSC, OIG representation, state Boards of Pharmacy, formulary committees; product recalls. Federal and state trial practice, arbitration, mediation, appellate litigation; grand jury and Department of Justice investigations
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