dcsimg Life Sciences - Government, Regulatory and Criminal Investigations

Life Sciences - Government, Regulatory and Criminal Investigations

In an era of heightened government scrutiny and oversight, life sciences companies face ever-increasing potential criminal and civil liabilities. McGuireWoods represents national and multinational companies and their directors, officers and employees in all aspects of criminal defense, related regulatory matters, and False Claims Act investigations and prosecution.

Our Government, Regulatory and Criminal Investigations (GRCI) practice draws on a team of former federal and state prosecutors and regulators to represent clients in some of the most difficult, serious and high-stakes circumstances. The team includes four partners who have held key leadership positions in the U.S. Department of Justice (DOJ), including service as a U.S. attorney for the Eastern District of Virginia, as DOJ section chief, as first assistant U.S. attorney and as assistant attorney general in charge of the DOJ’s National Security Division (NSD). Other partners have served as assistant U.S. attorneys in offices across the country. Our team also includes a former first general counsel to the UK’s Serious Fraud Office (SFO) and special counsel and acting deputy general counsel to the U.S. Federal Bureau of Investigation (FBI).

McGuireWoods’ lawyers provide scalable, responsive approaches to client issues that yield the best possible results for their unique businesses and circumstances. We regularly conduct audits, investigations and training to resolve internal issues, defend external investigations, and establish or strengthen compliance programs for clients worldwide. Our group is well versed in matters involving the Foreign Corrupt Practices Act (FCPA), government contracting, securities laws, money laundering and export controls.

We provide counsel across major substantive areas, including the UK Bribery Act of 2010, environmental enforcement, immigration enforcement, Securities and Exchange Commission (SEC) and corporate compliance, internal investigations, qui tam complaints, energy enforcement, and congressional ethics and other inquiries. Our experience includes matters involving Food and Drug Administration (FDA) regulations, federal and state anti-kickback fraud and abuse laws, and federal and state self-referral laws, including Stark laws.

We work closely with the firm’s other practice groups, our full-service public affairs subsidiary McGuireWoods Consulting LLC, and — for investigations involving large volumes of documents — our Discovery Counsel Services (DCS) practice. With two offsite facilities capable of housing up to 220 e-discovery document reviewers simultaneously, DCS has developed and tested best practices that have proven their value in government inquiries and complex litigation.

Blogs

Bribery Library
Subject to Inquiry

CONTACTS

Adam Greaves Partner T: +44 20 7632 1649
Jeffrey E. Rogers Partner T: +1 312 750 8686

BLOG

FDA Life

Brian Malkin Brian J. Malkin
Senior Counsel
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

7 Saint Paul Street
Suite 1000
Baltimore, MD 21202-1671

T: +1 202 857 1704
F: +1 202 828 2964
vCard

T:+1 202 857 1704
F: +1 202 828 2964

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Legal Alert

EU Medical Device Rules Continue to Progress

FDA Life
May 27, 2014
Legal Alert

EU Medical Device Rules

New Rules Are Nearly There But Not Quite

FDA Life
May 15, 2014
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