Life Sciences - FDA Regulatory

McGuireWoods’ Life Science – Food and Drug Administration (FDA) Regulatory Industry Team provides strategic guidance to life science companies involved in the manufacture and distribution of pharmaceuticals, biologics, and medical devices. Our mission is to solve problems efficiently, add value and implement strategies that help clients achieve their ultimate goals.

McGuireWoods believes that a holistic, multidisciplinary approach to health sciences products is the only way to effectively navigate your business. Thus, we have created a team of regulatory, policy counsel, and strategic compliance consulting professionals. We partner with clients from emerging-growth companies to large pharmaceutical, biotechnology, medical device companies, and academic institutions to develop, implement, and monitor regulatory programs from product development through launch, commercialization, and quality management. Our goal is to become an integral and efficient component of your business.

Regulatory Guidance

Our lawyers provide pharmaceutical and medical device manufacturers and other health science companies with strategic regulatory guidance and preventative liability consulting. At whatever stage of your business, we can analyze your compliance strategy, prepare and file FDA submissions, provide benchmarking audit and analysis of your regulatory and liability postures, establish and monitor applicable internal compliance programs, and take you through implementation. In addition to drafting or reviewing documents required to obtain approval of new products, we guide our clients in the highly scrutinized area of product promotion, often reviewing advertising and marketing initiatives for FDA and Federal Trade Commission (FTC) compliance. We also draw on the resources of our full-service public affairs subsidiary, McGuireWoods Consulting, to provide strategic communications and government relations services.

We stay abreast of changes to regulatory policy and procedure–especially in this new era of heightened regulation and enforcement. We likewise monitor the product liability landscape because, in the current climate, litigation prevention counseling can be your soundest business investment. Should claims arise, we believe that preventative measures are the most solid foundation on which to build a legal defense.

Compliance

With respect to day-to-day FDA compliance, we assist clients with developing standard operating procedures (SOPs) to comply with FDA directives and current Good Manufacturing Practices (cGMP), quality system regulation (QSR) and inspections, as well as compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). We analyze client compliance positions against FDA regulatory requirements and policies. We also assist clients with understanding their current compliance positions, and develop regulatory solutions that meet both their compliance requirements and business needs.

Litigation

Litigation prevention is a valuable business investment in today’s market, and we regularly advise clients on risk-management and litigation-avoidance strategies. When business disputes, government investigations or law enforcement actions arise, our team provides a strong defense at every stage of pre-trial, trial and appellate processes. We have defended individuals and companies in various types of FDA-related litigation, including grand jury investigations, criminal prosecutions, and civil regulatory and enforcement matters in federal and state courts. Among other matters, we have represented companies in numerous seizure and injunction actions.

International

We have exclusive consulting agreements with former FDA managers, connections with contact research organizations, and myriad contract experts in science and technology. We also have a premiere international presence. Through our own worldwide offices and international affiliates, we can provide the highest caliber regulatory services for life science companies in most countries around the world.

CONTACTS

Brian J. Malkin Senior Counsel T: +1 202 857 1704 Email
Stephanie A. Kennan Sr. VP, Federal Public Affairs McGuireWoods Consulting LLC T: +1 202 857 2922 Email

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FDA Life

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Mark E Anderson Mark E. Anderson
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106
Email
T: +1 919 755 6678
F: +1 919 755 6581
vCard
George J Barry III George J. Barry III
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534
Email
T: +1 404 443 5734
F: +1 404 443 5753
vCard
Scott Becker Scott Becker
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 750 6016
F: +1 312 920 6135
vCard
Ginny Boland Ginny Boland
VP, MWCAdvocacy McGuireWoods Consulting LLC
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 1907
F: +1 804 775 1061
vCard
Bryan C Brantley Bryan C. Brantley
Partner
EQT Plaza
625 Liberty Avenue
23rd Floor
Pittsburgh, PA 15222-3142
Email
T: +1 412 667 7983
F: +1 412 667 7971
vCard
William Bushman William G. Bushman
Associate
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 1806
F: +1 804 775 1061
vCard
Kathleen H Dooley Kathleen H. Dooley
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 343 2347
F: +1 704 444 8755
vCard
Christina M Egan Christina M. Egan
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 750 8644
F: +1 312 698 4502
vCard
Christopher K Greene Christopher K. Greene
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534
Email
T: +1 404 443 5721
F: +1 404 443 5692
vCard
J. Curtis Griner J. Curtis Griner
Associate
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 343 2013
F: +1 704 373 8833
vCard
Matthew Hall Matthew Hall
Partner
rue des Colonies 56 - box 3
1000 Brussels
Email
T: +32 2 629 42 34
F: +32 2 629 42 22
vCard
Steven J Keeler Steven J. Keeler
Partner
Court Square Building
310 Fourth Street, N.E.
Suite 300
Charlottesville, VA 22902-1288

1750 Tysons Boulevard
Suite 1800
Tysons, VA 22102-4215
Email
T: +1 434 977 2512
F: +1 434 980 2259
vCard

T:+1 703 712 5138
F: +1 434 980 2259

Nathan A Kottkamp Nathan A. Kottkamp
Partner
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 1092
F: +1 804 698 2072
vCard
Timothy H Kratz Timothy H. Kratz
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534
Email
T: +1 404 443 5730
F: +1 404 443 5784
vCard
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
Email
T: +1 202 857 1704
F: +1 202 828 2964
vCard

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

Patrick G. Martin
Sr. VP, Federal Public Affairs McGuireWoods Consulting LLC
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040
Email
T: +1 202 857 1700
F: +1 202 828 3326
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Yves Melin Yves Melin
Partner
rue des Colonies 56 - box 3
1000 Brussels
Email
T: +32 2 629 42 26
F: +32 2 629 42 22
vCard
Raj Natarajan Raj Natarajan
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 343 2330
F: +1 704 353 6147
vCard
Stephen Older Stephen Older
Partner
1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106
Email
T: +1 212 548 2122
F: +1 212 715 2307
vCard
Robert Plotkin Robert Plotkin
Partner
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106
Email
T: +1 202 857 1750
F: +1 202 828 2970
vCard

T:+1 212 548 7098
F: +1 212 548 2150

Megan Rachford Meghan M. Rachford
Associate
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534
Email
T: +1 404 443 5740
F: +1 404 443 5681
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Floretine Sneij Florentine Sneij
Associate
rue des Colonies 56 - box 3
1000 Brussels
Email
T: +32 2 629 42 48
F: +32 2 629 42 22
vCard
Cedric Tan Cedric C.Y. Tan
Partner
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040
Email
T: +1 202 828 2812
F: +1 202 828 2977
vCard
R. Trent Taylor R. Trent Taylor
Partner
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 1182
F: +1 804 225 5409
vCard
Rachelle Thompson Rachelle H. Thompson
Associate
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601
Email
T: +1 919 755 6572
F: +1 919 755 6591
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Event

8th Annual Pharmaceutical and Medical Device Conference

Thursday, November 10, 2016
Chicago, IL
Speaking Engagement

American Conference Institute's Fourth Annual FDA Boot Camp

Medical Devices Edition

July 20-22, 2016
Chicago, IL
Speaking Engagement

2016 FDLI Annual Conference

May 5, 2016
Washington, DC
Speaking Engagement

11th Summit on Biosimilars

Analyze the Impacts of the Regulatory Landscape on Commercial Potential, Promotion and Market Access of Biosimilars

Friday, January 29, 2016
Alexandria, VA
Speaking Engagement

FDLI Enforcement, Litigation, and Compliance

December 9-10, 2015
Washington, DC
Event

7th Annual Medical Device and Life Sciences Conference

November 19, 2015
Chicago, IL
Speaking Engagement

Amarin and the Future of Off-Label Promotion

November 16, 2015
Webinar
Speaking Engagement

Pennsylvania Bar Institute 21st Annual Meeting

November 4 - 5, 2015
Philadelphia, PA
Speaking Engagement

18th Annual IGPA Conference

September 17, 2015
Toronto, ON
Speaking Engagement

Benefit-Risk Assessment & Decision Making Summit

Methodologies for Patient-Centered Benefit-Risk Profiles to Ensure Product Efficacy and Safety

August 6, 2015
Alexandria
Speaking Engagement

ACI's 6th Annual Summit on Biosimilars

The Definitive Forum on the Legal, Regulatory, Patent, and Commercial Realities of Follow-On Biologics

June 2, 2015
New York, NY
Speaking Engagement

2015 FDLI Annual Conference

April 20, 2015
Washington, DC
Speaking Engagement

11th EGA Legal Affairs Forum

March 27, 2015
Brussels
Speaking Engagement

Food, Drug and Cosmetic Law Section Annual Meeting

January 29, 2015
New York City, NY
Speaking Engagement

7th Risk Evaluation and Mitigation Strategies Summit

January 22, 2015
Arlington, VA
Speaking Engagement

Climbing the Regulatory Summit

Regulatory and Clinical Trial Quandaries

December 10, 2014
Johns Hopkins University, Montgomery County Campus
Event

6th Annual Medical Device and Life Sciences Conference

November 18, 2014
Chicago, IL
Speaking Engagement

Europe v. U.S. Food, Drug, Device & Tobacco Regulation & Policy

Emerging Issues and Comparative Analysis

November 14, 2014
Brussels
Speaking Engagement

AdvaMed 2014: The MedTech Conference

October 7, 2014
Chicago, IL
Results 1-20 of 36
Results 1-20 of 38
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Legal Alert

Patent Settlement Update for Pharmaceutical Cases in Europe

FDA Life
January 12, 2016
Legal Alert

FDA Finalizes First Two Rules Under FSMA

September 14, 2015
Legal Alert

Amarin Wins Truthful Off-Label Speech Challenge

FDA Life
August 10, 2015
Legal Alert

EU Medical Device Update

FDA Life
July 20, 2015
Results 1-20 of 38