Overview
Good Manufacturing Practices (GMPs) / Quality Management System Regulation (QMSR)
We regularly counsel global pharmaceutical, biotechnology, and medical device companies, as well as drug compounders, on a variety of manufacturing and quality issues. Key areas of focus include good manufacturing practice (GMP) requirements, industry quality standards, and guidelines, related interactions with the FDA, product recalls, internal compliance investigations, and contractual relationships with suppliers and other third parties involved in manufacturing. Our team is highly experienced in helping companies respond to FDA Warning Letters and Form 483s, as well as in negotiating injunctions and consent decrees with the FDA and the Department of Justice (DOJ). We also have experience advising global life sciences companies on establishing proper supply chain controls and responding to FDA import alerts and detentions relating to alleged quality deficiencies.
Safety Surveillance and Risk Management
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.
State Pharmacy & Drug Distribution
The distribution of pharmaceutical products is governed by an increasingly complex web of federal and state requirements. Our team advises pharmaceutical manufacturers, wholesale distributors, third-party logistics providers, and pharmacy chains on compliance with the Drug Supply Chain Security Act (DSCSA), including product tracing, verification, and serialization requirements. We also counsel clients on controlled substance registration and reporting obligations under federal and state law, and interactions with the DEA and state boards of pharmacy.
