Life Sciences

For decades, Holland & Knight's Life Sciences Team has served as a strategic business partner to a nationwide roster of clients. Our experienced life sciences attorneys take a comprehensive, multidisciplinary approach to serving the needs of clients in this vital industry. Holland & Knight has more than 400 dedicated healthcare and life sciences attorneys, making us the largest healthcare law firm in the nation according to Modern Healthcare.

For companies across the life sciences industry, we have the range and depth of legal experience essential to dealing effectively – throughout a product's life cycle – with today's increasingly complex regulatory and policy challenges, many of which are driven by the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). Our experience includes:

• business planning and startup
• finance, mergers and acquisitions (M&A) and other corporate transactions
• healthcare regulatory matters, including public and private reimbursement issues
• federal and state legislation and appropriations
• litigation, including intellectual property (IP) matters, product liability and mass tort defense
• strategic communications

Holland & Knight's Life Sciences Team is able to draw upon the firm's considerable resources, including experienced lawyers and professionals from related practices in 29 offices across the United States, such as Washington, D.C., New York, Atlanta, Boston, Chicago, Dallas, Houston, Los Angeles, San Francisco, Miami, Nashville and other major cities.

FDA Experience

We provide counsel on all FDA issues throughout the review and approval/clearance process, including compliance with marketing and labeling rules, as well as assisting clients in applying for appropriate product codes to facilitate the tracking and future payment of FDA-regulated products.

We also advise dietary supplement and food companies on their FDA responsibilities, including New Dietary Ingredient Notifications (NDIN), Generally Recognized as Safe (GRAS) requirements, and advertising and promotion rules.

Moreover, we represent and advocate for life sciences companies on Capitol Hill, at the White House and across the federal government.

M&A, Private Equity and Venture Capital

Our Life Sciences Team has extensive experience providing counsel in transactional matters. From due diligence and the evaluation of the risks associated when entities regulated by the FDA and other government agencies are involved in commercial transactions, our attorneys have the skills needed to successfully close acquisitions, dispositions, private equity recapitalizations and venture capital investments. We represent privately held and publicly traded life sciences companies in transactions ranging from the middle market to multibillion-dollar deals, including U.S. and cross-border transactions.

Life Sciences Litigation

Pharmaceutical companies, manufacturers of durable medical equipment (DME) and medical devices, biotechnology and other life sciences companies rely on Holland & Knight's industry experience in litigation matters ranging from patent infringement and IP matters to disputes involving product development, manufacturing, supply and service contracts, and other agreements.

Product Liability

Holland & Knight has vast experience defending life sciences companies in high-profile product liability litigation in courtrooms across the country. With a thorough understanding of the life sciences industry and the regulatory framework in which it operates, our attorneys handle and manage complex, consolidated and large volume mass tort litigations for pharmaceutical and medical device companies.

Public Policy

Life sciences clients often seek guidance from Holland & Knight attorneys and policy advisors to help secure vital policy objectives through skillful representation before the U.S. Congress, FDA, CMS and other federal agencies. We have a proven track record of representing individual companies as well as organizing and managing diverse coalitions of healthcare stakeholders to achieve policy objectives. Whether a matter requires informal consultation with agency or congressional staff, participation in public meetings, advocacy for particular report or bill language, or the preparation of comments on proposed rules or guidance, Holland & Knight has the talent and resources to handle the matter effectively and efficiently.

A Multidisciplinary Approach

To maximize your opportunity for a beneficial outcome on an issue, we assemble focused teams of attorneys and professionals to blend the necessary substantive knowledge with procedural know-how to move the matter through the litigation, legislative and regulatory processes.

Our clients, spanning all industry sectors and ranging from startup ventures to multinational corporations and trade associations, trust us with their most challenging business problems. Clients know that they can rely on Holland & Knight's Life Sciences Team for practical, efficient solutions rooted in a sophisticated knowledge of their business that comes only from deep immersion and understanding in the life sciences industry and decades of dedicated service