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.