Life Sciences - FDA Regulatory

McGuireWoods’ Life Science – Food and Drug Administration (FDA) Regulatory Industry Team provides strategic guidance to life science companies involved in the manufacture and distribution of pharmaceuticals, biologics, and medical devices. Our mission is to solve problems efficiently, add value and implement strategies that help clients achieve their ultimate goals.

McGuireWoods believes that a holistic, multidisciplinary approach to health sciences products is the only way to effectively navigate your business. Thus, we have created a team of regulatory, policy counsel, and strategic compliance consulting professionals. We partner with clients from emerging-growth companies to large pharmaceutical, biotechnology, medical device companies, and academic institutions to develop, implement, and monitor regulatory programs from product development through launch, commercialization, and quality management. Our goal is to become an integral and efficient component of your business.

Regulatory Guidance

Our lawyers provide pharmaceutical and medical device manufacturers and other health science companies with strategic regulatory guidance and preventative liability consulting. At whatever stage of your business, we can analyze your compliance strategy, prepare and file FDA submissions, provide benchmarking audit and analysis of your regulatory and liability postures, establish and monitor applicable internal compliance programs, and take you through implementation. In addition to drafting or reviewing documents required to obtain approval of new products, we guide our clients in the highly scrutinized area of product promotion, often reviewing advertising and marketing initiatives for FDA and Federal Trade Commission (FTC) compliance. We also draw on the resources of our full-service public affairs subsidiary, McGuireWoods Consulting, to provide strategic communications and government relations services.

We stay abreast of changes to regulatory policy and procedure–especially in this new era of heightened regulation and enforcement. We likewise monitor the product liability landscape because, in the current climate, litigation prevention counseling can be your soundest business investment. Should claims arise, we believe that preventative measures are the most solid foundation on which to build a legal defense.

Compliance

With respect to day-to-day FDA compliance, we assist clients with developing standard operating procedures (SOPs) to comply with FDA directives and current Good Manufacturing Practices (cGMP), quality system regulation (QSR) and inspections, as well as compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). We analyze client compliance positions against FDA regulatory requirements and policies. We also assist clients with understanding their current compliance positions, and develop regulatory solutions that meet both their compliance requirements and business needs.

Litigation

Litigation prevention is a valuable business investment in today’s market, and we regularly advise clients on risk-management and litigation-avoidance strategies. When business disputes, government investigations or law enforcement actions arise, our team provides a strong defense at every stage of pre-trial, trial and appellate processes. We have defended individuals and companies in various types of FDA-related litigation, including grand jury investigations, criminal prosecutions, and civil regulatory and enforcement matters in federal and state courts. Among other matters, we have represented companies in numerous seizure and injunction actions.

International

We have exclusive consulting agreements with former FDA managers, connections with contact research organizations, and myriad contract experts in science and technology. We also have a premiere international presence. Through our own worldwide offices and international affiliates, we can provide the highest caliber regulatory services for life science companies in most countries around the world.