Life Sciences

Emerging, middle-market and established companies alike require sophisticated legal representation that is cost-effective and capable of responding to the rapidly changing demands of regulators and customers. As counsel to domestic and global life sciences companies at every stage of development, the Life Sciences industry group at McGuireWoods offers clients a single, coordinated team of lawyers with deep, varied experience. Our clients recognize that they are treated as firm clients and not as those of a single practitioner or office location.

We counsel clients in all major areas of law affecting life sciences businesses and at every step in the product lifecycle. We provide guidance on corporate transactions and matters involving company structure and formation, financing, facilities acquisition and leasing, and vendor contracts. We have extensive experience in healthcare and life sciences-related regulatory requirements, including compliance audits and policies, FDA notification and approvals, development of pricing programs, and reimbursement and third-party payor processes.

Regulatory policies walk hand in hand with legislative mandates. In conjunction with our full-service public affairs subsidiary, McGuireWoods Consulting, we provide strategic communications and government relations guidance that helps businesses and industry coalitions shape pending legislation and respond to state and federal initiatives.

When disputes or law enforcement investigations arise, we provide aggressive defense against allegations of theft, product liability and mass torts. We represent clients facing government inquiries and administrative actions involving a broad range of issues, from securities disclosures and financial accounting rules to data privacy, antitrust and other compliance requirements. We also investigate and vigorously pursue counterfeiters, gray marketers and abusers of supply chain systems.

As life sciences businesses grow and transform, capital sourcing and other forms of financing become an important concern. We represent clients in negotiations with private equity investors, commercial banks and other financial institutions. Similarly, our depth of experience in public offerings and middle-market mergers and acquisitions adds value to growth and technology companies when exploring liquidity events.

While life sciences businesses share many of the same concerns as companies in other industries, these issues must be addressed in the context of this highly regulated sector of the economy. Our multidisciplinary team of lawyers provides broad-spectrum, coordinated counsel on all major areas of law affecting clients’ operations and strategy. These core areas of service include labor and employment, intellectual property, state and local taxation, and international trade. Our experience in these and other areas of law enables us to provide prompt, effective counsel in the dynamic life sciences marketplace.

CONTACTS

Timothy H. Kratz Partner T: +1 404 443 5730 Email
Kathleen H. Dooley Partner T: +1 704 343 2347 Email
Raj Natarajan Partner T: +1 704 343 2330 Email

BLOG

FDA Life

Results 1-20 of 111
Show All

RESULTS DEPEND ON A VARIETY OF FACTORS UNIQUE TO EACH CASE. PRIOR RESULTS DO NOT GUARANTEE OR PREDICT A SIMILAR OUTCOME.

Representative Matter

Medical device and pharmaceutical manufacturers

Representation of medical device and pharmaceutical manufacturers in outsourced manufacturing arrangements.
Representative Matter

Various life sciences clients

Counsel clients regarding Medicare and Medicaid Anti-Kickback issues, Medicare coverage and payment issues, and HIPAA issues raised by the storage, receipt or transmission of patient health information.
Representative Matter

Pharmaceutical and medical device contract manufacturers

Regularly represent pharmaceutical and medical device contract manufacturers in negotiation of outsourced manufacturing agreements for medical devices, pharmaceuticals and biotech products.
Representative Matter

Former general counsel of large pharmaceutical services and products company

Represent former general counsel of large publicly traded provider of pharmaceutical services and products in False Claims Act, and related criminal investigation involving allegations of illegal purchasing arrangement with manufacturer of pharmaceuticals.
Representative Matter

Generics pharmaceutical company

Defended generics pharmaceutical company against patent infringement claims asserted in lawsuits filed in the U.S. District Court for the Northern Districts of Illinois and the Northern District of West Virginia by the manufacturer of the brand name treatment for seizure disorders utilizing the active ingredient divalproex.
Representative Matter

World-class academic and health care system

Represent world-class academic and health care system in multi-plaintiff litigation arising from allegations that falsified genomic research was allowed to proceed to clinical trials with the enrollment and treatment of cancer patients.
Representative Matter

Investment in a manufacturer and distributor of laboratory equipment

Representation of a F.N.B. Capital Partners in connection with its investment in a manufacturer and distributor of laboratory equipment.
Representative Matter

Canadian-based company

Assisted a Canadian-based company to register its establishment with FDA and evaluate FDA’s mobile medical application guidances for classification of its activity monitor device adapted for rehabilitative use, which incorporated smartphone application connectivity and monitoring.
Representative Matter

Diabetes management company

Determined proposed medical device classification and developed regulatory strategy for clearing/approving an artificial pancreas incorporating marketed glucose monitors and insulin pumps and smartphone applications and algorithms, in view of FDA’s mobile medical application and information technology guidances.
Representative Matter

Biosimilar manufacturer

Assisted biosimilar manufacturer with developing clinical trial strategies for approval, which included considering biosimilar approvals in other countries, such as possible 505(b)(2) NDA approval strategies.
Representative Matter

Mezzanine fund

Represented a provider of mezzanine capital in its mezzanine investment in a lab company, which the lab company used to help fund an acquisition.  
Representative Matter

Major dietary ingredient manufacturer

Provide assistance to a major dietary ingredient manufacturer with reviewing food and dietary supplement labeling for compliance with FDA regulations and requirements, including Dietary Supplement Health and Education Act (DSHEA) requirements and structure/function claims.
Representative Matter

One of the world's leading suppliers to the life science industries

Represented one of the world's leading suppliers to the life science industries, based in Switzerland, in the acquisition by tender offer of an NYSE-traded chemicals company for $1.2 billion.
Representative Matter

Indiana-based bank owned SBIC Fund

Representation of an Indiana-based bank owned SBIC Fund on a bridge financing in a developer of drugs for ovarian and lung tumors.
Representative Matter

Leading generic and specialty pharmaceutical company

After a three week jury trial, obtained a unanimous defense verdict for one of the world's leading generic and specialty pharmaceutical companies.
Representative Matter

Leading generic and specialty pharmaceutical company

Representation of a pharmaceutical manufacturer in a wrongful death case, obtaining a defense verdict after an hour of deliberation.
Representative Matter

Generic drug manufacturer

Assisted generic drug manufacturer in abbreviated new drug application (ANDA) patent litigation related to advertising and promotion material for marketed products, including reviews by the Division of Prescription Drug Promotion (OPDP) with regard to the listing or assertion of method-of-use patents.
Representative Matter

Major life sciences organization

Advising on UK data protection requirements in relation to medical research and patient records for drug trials, working as part of a team of European lawyers to provide coordinated advice to a major life sciences organisation.
Representative Matter

Major drug manufacturer

Provide assistance to a major drug manufacturer with drafting citizen petitions to FDA regarding generic drug formulations and testing.
Representative Matter

Medical device manufacturer

Provide assistance to medical device manufacturer with determining appropriate classification for their proposed devices, including assisting with their 510(k) clearances and premarket approval applications (PMAs).
Results 1-20 of 111
Results 1-25 of 93
Show All
Brad Alexander Brad L. Alexander
Sr. VP and Director, Georgia Gov. Relations McGuireWoods Consulting LLC
100 Peachtree Street, N.W.
Suite 2200
Atlanta, GA 30303-1931
Email
T: +1 404 443 5811
F: +1 404 443 5682
vCard
Ashley Allen Ashley K. Allen
Counsel
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 1918
F: +1 804 775 1061
vCard
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
Brian D Barger Brian D. Barger
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 343 2072
F: +1 704 343 2300
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
Evan Bayh Evan Bayh
Partner
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040
Email
T: +1 202 828 2825
F: +1 202 828 3331
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
Kenneth D Bell Kenneth D. Bell
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 373 4620
F: +1 704 373 8836
vCard
Samuel C Bernstein Samuel C. Bernstein
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 849 8222
F: +1 312 698 4571
vCard
William J Boddy William J. Boddy
Associate - Solicitor Advocate
11 Pilgrim Street
London EC4V 6RN
United Kingdom
Email
T: +44 20 7632 1625
F: +44 20 7632 1638
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
Ryan Bonistalli Ryan E. Bonistalli
Associate
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 1014
F: +1 804 698 2036
vCard
Alex J Brackett Alex J. Brackett
Partner
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 4749
F: +1 804 698 2089
vCard
Caitlin Bradley Caitlin O. Bradley
Associate
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 1126
F: +1 804 698 2031
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
Meggan Michelle Bushee Meggan Michelle Bushee
Associate
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 343 2360
F: +1 704 805 5085
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
Michelle Calloway Michelle E. Calloway
Counsel
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916
Email
T: +1 804 775 7819
F: +1 804 698 2189
vCard
Holly Carnell Holly Carnell
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 849 3687
F: +1 312 698 4504
vCard
Charles D. Case
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601
Email
T: +1 919 755 6698
F: +1 919 775 6675
vCard
Jeffrey J Chapman Jeffrey J. Chapman
Partner
1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106
Email
T: +1 212 548 7060
F: +1 212 715 6277
vCard
Geoffrey C Cockrell Geoffrey C. Cockrell
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818
Email
T: +1 312 849 8272
F: +1 312 698 4572
vCard
J. D Costa J. D. Costa
Associate
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146
Email
T: +1 704 343 2236
F: +1 704 353 6192
vCard
Dave Dargatis David G. Dargatis
Senior Counsel
1750 Tysons Boulevard
Suite 1800
Tysons, VA 22102-4215
Email
T: +1 703 712 5080
F: +1 703 712 5050
vCard
Patrick A De Ridder Patrick A. De Ridder
Partner
Gateway Plaza
800 East Canal Street
Richmond, VA 23219-3916

11 Pilgrim Street
London EC4V 6RN
United Kingdom
Email
T: +1 804 775 4369
F: +1 804 698 2221
vCard

T:+44 20 7632 1716
F: +44 20 7632 1638

Results 1-20 of 63
Show All
Speaking Engagement

2016 Danish Biotech Conference

April 12-13, 2016
New York, NY
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
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
Speaking Engagement

Redefining Early Stage Investments

The Case for Small Markets with Large Returns: Orphans/Rare Disease Panel

September 17, 2014
Boston, MA
Results 1-20 of 63
Results 1-20 of 179
Show All
Legal Alert

To BREXIT or Not to BREXIT? That is the Question.

But What are the Consequences?

June 21, 2016
Legal Alert

Patent Settlement Update for Pharmaceutical Cases in Europe

FDA Life
January 12, 2016
Results 1-20 of 179