Life sciences companies face a daunting array of regulatory compliance requirements at every stage of the product lifecycle. McDermott’s regulatory lawyers in the United States and Europe, in conjunction with lawyers from MWE China Law Offices, help clients take proactive steps to identify and manage potential risks, respond to inquiries by state, national and international agencies, and, if necessary, pursue resolution of disputes in court and before administrative and other tribunals.
We provide comprehensive advice to pharmaceutical, biotechnology, medical device and dietary supplement companies, as well as to clinical research organizations and individual researchers, medical centers and other health care providers, in all aspects of the development, clinical trial, product application and review, manufacture, marketing and reimbursement of drug, biologic, device and other products.
We advise clients on regulatory submissions, US Food and Drug Administration (FDA) review, current Good Manufacturing Practice (cGMP), advertising and promotion, supply chain and distribution, post-market surveillance, internal compliance program implementation and monitoring, and other pre- and post-market regulatory issues. We represent clients in, and help resolve, issues arising from clinical trial oversight, inspections, compliance and enforcement investigations and actions of the FDA, Department of Justice (DOJ), other federal and state agencies, and Congress, as well as in qui tam and other litigation.
Given the breadth of our clients’ regulatory concerns, a coordinated approach to legal issues is a necessity. Our team is fully integrated with our top-tier ranked global health practice, as well as with lawyers from our food, beverages and agribusiness, antitrust, environmental, corporate and securities, and other core practices.
McDermott’s Antitrust & Competition Practice Group is recognized as one of the world’s leading antitrust/competition practices by Chambers USA, U.S. News–Best Lawyers and Global Competition Review. The 65-lawyer group includes more than 15-plus members who served previously as former federal prosecutors and regulatory officials with primary responsibility for antitrust matters. Our practice encompasses US, European and—through a strategic partnership with MWE China Law Offices—Chinese law, as well as the competition laws of other countries throughout the world. We provide a full range of antitrust counsel, including transactional representation, defense of government investigations and litigation, and antitrust training.
Through our strategic alliance with MWE China Law Offices, we provide regulatory counsel to life sciences companies with investments, relationships and operations in the People’s Republic of China. Environmental and food safety have become focal issues in recent years, and MWE China Law Office’s relationship with the Shanghai Municipal Food and Drug Administration is one example of the firm’s ability to work with government officials and businesses to improve communications and compliance. Other recent matters include representing a global health care leader in its filings and other communications with Chinese antitrust authorities in relation to its merger with one of the world’s largest pharmaceutical companies.
Our Brussels-based regulatory lawyers offer coordinated regulatory and advisory counsel on the regulatory schemes of the European Commission and Member States, as well as on international and cross-border issues. We work with clients to promote the development of business-friendly regulatory programs and rules, and to interpret and comply with existing EU requirements, international laws and treaties. Among other areas, we provide guidance on privacy and data protection, chemicals and hazardous substances, marketing, advertising and labeling standards, pan-European pharmaceutical approvals and excise duties.
Members of McDermott’s US Food and Drug Administration (FDA) practice are nationally recognized as leading lawyers in FDA law by US News Best Lawyers and LMG Life Sciences. We provide comprehensive advice to pharmaceutical, biotechnology, medical device, dietary supplement and food companies; clinical research organizations; and individuals, medical centers, physician practices and other health care providers in all aspects of the development, clinical research, product application and review, manufacture, distribution, marketing and reimbursement of drug, biologic, device and other products regulated by the FDA.