We regularly counsel global pharmaceutical and device companies on manufacturing-related regulatory issues, advise clients on FDA inspections, help clients draft “483” and Warning Letter responses and when necessary, respond to FDA enforcement actions such as product seizures and injunction actions. Our team has negotiated GMP consent decrees with the FDA and the U.S. Department of Justice and advised clients on implementing consent decree requirements. We also have experience advising global pharmaceutical companies on how to establish proper supply chain controls and how to respond to FDA import detentions and import alerts relating to alleged GMP deficiencies.
Drug and device safety surveillance and risk management are critical to the long-term success of a product. Our team has extensive experience counseling clients on compliance with pharmacovigilance requirements, negotiating and implementing risk evaluation and mitigation strategies (REMS) for global pharmaceutical brands, and advising drug and device clients on post-approval labeling changes, product recalls and safety inquiries.