Industries: Life Sciences

Latest News:

Werling Interviewed on Impact of Healthcare Reform (8/24/2010)

FDA Releases Anticipated Preliminary Report Tightening Medical Device Regulations (8/4/2010)

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McGuireWoods has extensive experience as counsel to growing health science companies at every stage of their development. With our work matching our clients’ business objectives, risk tolerance, time parameters, and resources, we are not just lawyers. We are business partners.

We understand the importance of legal representation that is responsive to the unique confluence of issues and demands on emerging and middle-market companies, who desire manageable legal assistance along with sophisticated representation.

All too frequently, this dichotomy forces a choice between a large firm with an unmanageable fee structure, and a smaller firm that lacks the depth and breadth of experience required to shepherd a company through its growth and success.

But at McGuireWoods, our Life Sciences Industry Group provides health science companies with the best of both worlds – a single team of interconnected attorneys with deep, varied experience all working together to provide that experience specifically to life sciences companies.

We counsel clients in virtually every area of this industry, including corporate structure, financing, contracts, intellectual property, trials, FDA notification and approval, sales and marketing regulation, government investigations and defense; healthcare compliance; pricing programs; reimbursement and third-party payors; counterfeiting, diversion and theft; product liability defense; executive employment contracts; stock-based and other incentive compensation plans; strategic partnership agreements and consulting agreements; trademark, trade dress, copyright and patent registration and protection; state and local taxation; and international trade. Our experience in the many areas of law affecting the life sciences sector enables us to provide prompt, effective counsel in response to changes in these dynamic markets.

In addition, our representation of private equity investors, commercial banks, and other financial institutions provides us with experience and contacts that benefit clients seeking further investment. Furthermore, our depth of experience in public offerings and middle market mergers and acquisitions adds value to growth and technology companies when exploring liquidity events.

Representative Life Sciences Services

  • Assisting clients with protecting their intellectual property and bringing products to market.
  • Handling structured financings, mergers, acquisitions and divestures.
  • Advising clients on product risk management.
  • Defending manufacturers and sellers in products liability litigation involving drugs, medical devices and biological products.
  • Counseling clients on strategies to comply with regulations governing the pre- and post-market lives of drugs or medical devices.
  • Establishing internal programs for compliance with adverse event reporting obligations.
  • Representing clients before the FDA on pre-market clearances, post-market reporting, and surveillance.
  • Coordinating responses to discovery directed at “product line” issues.
  • Developing strategies for reimbursement from third-party payors for drug or device-related therapy.
  • Creating compliance programs.
  • Defending pharmaceutical and medical device companies in commercial disputes.
  • Litigating ANDA cases.

Life Sciences Teams