Greer O. Lautrup

GREER LAUTRUP is an experienced food and drug law lawyer who represents pharmaceutical, biologics, medical device and dietary supplement manufacturers in a wide variety of civil, criminal, and regulatory matters. She was recognized in LMG Life Sciences (2012–2014) as a “life science star.”

Greer’s particular areas of focus include assisting U.S. and international companies in complying with the Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR). She regularly assists companies in preparing for FDA inspections and with responses to FDA Form 483s and Warning Letters, as well as with adverse event and medical device reporting. She has worked with companies throughout the world on GMP and QSR compliance, including in China, India, Europe, and Australia. She has also conducted numerous internal investigations involving allegations of off-label promotion and healthcare fraud and abuse. Her extensive practice includes advising clients on a host of compliance issues, drafting healthcare compliance policies and procedures, and developing content for and conducting compliance training programs.

A sampling of Greer’s experience includes:

• Assisted a Chinese medical device company in preparing for and responding to their first FDA inspection
• Worked with numerous dietary supplement companies to implement GMP programs and prepare for and respond to FDA inspections
• Assisted a major OTC pharmaceutical company in implementing a Consent Decree
• Developed and led a compliance strategy for a medical device company facing FDA enforcement action which resulted in a successful follow up inspection
• Conducted a three-continent GMP review focusing on aseptic practices for a U.S.–based multinational pharmaceutical company
• Led a 27-country crisis management effort for a multinational food company facing allegations of product quality issues
• Drafted FDA/healthcare compliance policies and procedures and related training for numerous pharmaceutical and medical device companies
• Negotiated a Corporate Integrity Agreement for a multinational pharmaceutical and medical device company
• Led an internal investigation of promotional practices for a small international pharmaceutical company doing business in the United States

Greer joined the firm following a clerkship with the Honorable Samuel G. Wilson, Chief Judge of the United States District Court for the Western District of Virginia. While at the University of Virginia School of Law, she was the Research and Projects Editor of the Virginia Journal of International Law and a Hardy Cross Dillard Fellow.

Prior to attending law school, Greer served for eight years as a Naval Intelligence Officer. Her military assignments included Intelligence Analyst and Briefer for: Secretary of Defense Richard Cheney; Chairman, Joint Chiefs of Staff, General Colin Powell; and the Secretary of the Navy during DESERT STORM.

Greer frequently speaks at legal and industry conferences and has also presented to FDA. A sampling of her speaking engagements includes the following:

• American Conference Institute, The Legal, Regulatory and Compliance Forum on Dietary Supplements, June 2013
• Food and Drug Law Institute (FDLI) training for at FDA on Good Manufacturing Practice