We draw upon our global experience working with emerging, middle-market and established life sciences companies to find innovative, effective solutions for clients. McGuireWoods lawyers understand that the success of a life sciences enterprise depends on solid working relationships with government, research and development companies, universities, privately and publicly held businesses, and the financial community. Our industry-focused team has a keen grasp of the intricate relationships among these parties.

A number of our lawyers hold scientific degrees and have in-house experience at life sciences companies and service providers. That means we have the fundamental knowledge to understand our clients' science, operations and business strategies. We strive to be part of our clients' team throughout the life cycle of their products, from development and navigating regulatory issues, to raising capital and marketing, and when necessary, advancing their interests in court.

Our multidisciplinary team offers services tailored to the needs of biotech, medical device, diagnostics and pharmaceutical companies at all stages of growth. We successfully serve clients in the following legal areas:

Corporate & Finance Transactions  – We advise on complex mergers and acquisitions, financings, public and private securities offerings and other capital-raising transactions, licensing agreements, joint ventures and strategic partnering arrangements. Our work with private equity investors, commercial banks and other financial institutions showcases our skills handling issues in the life sciences investment space. The volume of deals we do each year has led Thomson Reuters and Bloomberg to consistently rank McGuireWoods among the top 10 M&A and corporate finance firms in the United States.

Regulatory & Compliance  – We counsel on compliance matters that arise during daily operations, strategic planning, and sales and marketing planning, including federal and state anti-kickback laws, FDA regulations, digital health and cyber security, and other regulations governing the manufacture, sale, distribution and marketing of pharmaceuticals, medical devices and other products. The team analyzes compliance strategies, prepares and files FDA submissions, provides benchmarking audits and analysis of regulatory and liability postures, establishes and monitors internal compliance programs, and takes clients through implementation.

Intellectual Property  – We understand the vital role of intellectual property in the industry, and are well versed in the regulatory framework that spurs innovation in the biotech, medical device, diagnostics and pharmaceutical space. We advise on patent prosecution and defense, patent portfolio strategy development, monitoring of competitive technologies, guidance on trademark, copyright, trade secret protection and enforcement issues, licensing, pursuit of counterfeiters and gray-market diverters, and transactional due diligence on behalf of investors.

Antitrust & Competition  – McGuireWoods’ global team of antitrust and competition lawyers excels at finding creative, practical ways for life sciences clients to compete aggressively while minimizing risks. Our lawyers assist clients with designing marketing and distribution systems that comply with antitrust laws, pricing and distribution issues, structuring joint ventures and strategic alliances, and conducting antitrust audits and compliance programs. They appear before courts and tribunals throughout the United States and Europe, and represent clients in matters such as cartels, parallel civil and criminal proceedings, and civil class actions and arbitrations.

Product Liability & Commercial Litigation   – Our decades of experience and ability to quickly understand the technical and medical principles involved in each case enable us to mount an effective defense against unwarranted claims and the tactics of plaintiffs’ counsel. We serve as lead defense counsel to life sciences companies in class actions, multidistrict litigation and individual cases involving devices, pharmaceuticals and biological products. Because of our significant work in this space, McGuireWoods is nationally recognized in product liability and mass tort litigation by Chambers USA and Legal 500.

McGuireWoods’ experience in these critical areas affecting life sciences companies enables us to provide prompt, effective counsel in response to changes in this dynamic market. In conjunction with our full-service public affairs subsidiary McGuireWoods Consulting, we also provide strategic communications and government relations guidance that helps life sciences businesses and industry coalitions shape pending legislation and respond to state and federal initiatives.

Experience

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    World-class academic and health care system

    Representation of a world-class academic and health care system arising from alleged exposure of thousands of surgical patients to a contaminated cleaning agent used on surgical instruments.

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    Various life sciences clients

    Advised clients on compliance with United States export control laws and economic sanctions.

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    Various life sciences clients

    Regularly counsel clients with on-site anticorruption review and investigation activities in Latin America, South America and Europe for multiple Fortune 500 clients.

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    Various life sciences clients

    Counsel clients regarding Medicare and Medicaid Anti-Kickback issues, Medicare coverage and payment issues, and HIPAA issues raised by the storage, receipt or transmission of patient health information.

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    Various life sciences clients

    Managed PBM projects including reviewing contracts, addressing Medicare reimbursement issues, and providing guidance in connection with pre-Part D discount card program.

Team Leaders

Full Team
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