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Associate Members

All 2016 new members are indicated with an asterisk (*)

Associate Members

Law Firms

Insurance

Consulting Groups

Akin Gump Strauss Hauer & Feld LLP* Medmarc 3D Communications*
Arnold & Porter LLP   A. T.  Kearney
Bass Berry & Sims

Educational Services

Accenture
Hogan Lovells US LLP UL EduNeering Avalere Health LLC
King & Spalding   Berkeley Research Group, LLC (BRG)*

Latham & Watkins LLP

Employment Services

Cognizant Technology Solutions
McGuire Woods LLP Korn Ferry Deloitte & Touche LLP
Norton Rose Fulbright  

L. E. K. Consulting LLC

Novasyte, LLC

Reed Smith LLP   Porzio Life Sciences, LLC
Ropes & Gray LLP   PricewaterhouseCoopers LLP
Sidley Austin LLP   Quintiles*
   

SalesForce4Hire, LLC

UL LLC

     
     

Business Intelligence

Supply Chain Management

Quality Management

Evaluate Group Ltd. Global Healthcare Exchange (GHX) MasterControl Inc.
    Pilgrim Quality Solutions
    Sparta Systems, Inc.
    Fisher Scientific*
     

Enterprise Management

Waste Management

SAP SE  
Siemens PLM Software    
     
     

Accounting

   
Baker Tilly Vichow Krause, LLP*    
     

3D Communications

3D Communications is preeminent in preparing pharma, biotech and device companies for FDA interactions, Advisory Committee meetings, and Market Access negotiations. We provided strategic counsel and hands-on implementation for nearly 150 Advisory Committee meetings and submissions. Our services include messaging, scripting, Q&A, slide development, briefing book writing, and communications coaching. 

Contact: Allison Dail, 919.301.8084

View our white papers

Do Public Hearing Participants Influence Outcomes of FDA Advisory Committee Meetings? 

Draft Guidance of Evaluation and Reporting of Age, Race and Ethnicity May Have Significant Impact On Medical Device Clinical Trials

Avoiding Common Pitfalls at FDA Device Panel Meetings

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Akin Gump Strauss Hauer & Feld LLP

Akin Gump Strauss Hauer & Feld LLP is a leading international law firm. From capitalization through postmarket representation, health care policy and legislative strategy, we work with clients to ensure that their global regulatory strategies and legislative interests are aligned to maximize opportunities for coverage and reimbursement, entry into new markets and further research and development.

Contact: Nathan A. Brown, Partner, Akin  Gump Strauss Hauer & Feld LLP

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A.T. Kearney

A.T. Kearney is a leading global management consulting firm with offices in more than 40 countries. Since 1926, we have been trusted advisors to the world's foremost organizations. A.T. Kearney is a partner-owned firm, committed to helping clients achieve immediate impact and growing advantage on their most mission-critical issues.

Contact: Siobhan Komnick, Managing Consultant

View our white papers

Medical Devices: Equipped for the Future?

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Accenture

Accenture is a global management consulting, technology services and outsourcing company, with more than 358,000 people serving clients in more than 120 countries. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world’s most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. The company generated net revenues of US$31.0 billion for the fiscal year ended Aug. 31, 2015.

Contact: Doug Mowen, Managing Director

View our white papers

Disrupt or Be Disrupted: Prescriptions for life sciences in the age of digital medicine

Accenture Technology Vision 2015 for Life Sciences

Patient Services: Pharma’s Best Kept Secret

Breaking free from the cost-cutting cycle in the life sciences industry

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Arnold & Porter LLP

Arnold & Porter LLP, an 800 lawyer firm with offices in the US and Europe, is ideally positioned to serve the needs of the biopharmaceutical and medical device community. Our team of more than 50 regulatory and compliance attorneys advise life sciences companies on addressing the risks confronted at each stage of product research and development, manufacturing, marketing, sales and distribution. We routinely advise companies on the implementation and enhancement of global compliance programs, and vigorously defend our clients in a broad range of investigations and enforcement matters.  

Contact: Daniel A. Kracov, Partner and Co-Chair, FDA & Healthcare Practice, or Allison Shuren, Partner and Co-Chair, FDA & Healthcare Practice

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Avalere

Avalere is a vibrant community of innovative thinkers dedicated to solving the challenges of the healthcare system. We deliver a comprehensive perspective, compelling substance, and creative solutions to help you make better business decisions. As an Inovalon company, we prize insights and strategies driven by robust data to achieve meaningful results.

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Baker Tilly

Baker Tilly is a nationally recognized, full-service accounting and advisory firm whose specialized professionals connect through refreshing candor and clear industry insight. We work with medical device, biotechnology, pharmaceutical, and medical technology companies through all stages of their lifecycle. Our comprehensive services address risk, business opportunities, management initiatives, and compliance. 

Contact: Mike McKee, Partner and Life Sciences Industry Leader, 612.876.4694

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Bass Berry

Bass, Berry & Sims PLC is a full-service law firm with more than 270 lawyers in Washington, D.C and Tennessee.  As one the of largest healthcare firms in the United States, Bass, Berry & Sims has a depth of healthcare and medical device experience that ranges from operational and regulatory compliance to government investigations and complex transactions. We offer advice that is conservative and practical when working with our clients to effectively manage their needs, including mergers and acquisitions, joint ventures, fraud and abuse, reimbursement, licensing and certification, corporate compliance, HIPAA privacy and security compliance. Our deep bench and historical industry perspective make our firm the stronger choice in today’s increasingly complex healthcare and medical device environment. 

Contact: John Kelly, Member 

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BRG

BRG is a leading global strategic advisory and expert consulting firm that provides independent expert testimony, regulatory, compliance and dispute consulting services to life sciences companies, law firms, and government agencies around the world. BRG is headquartered in Emeryville, California, with offices across the United States and in Australia, Canada, Hong Kong, Latin America, and the United Kingdom.

Contact: Katherine Norris, Director, 202.753.5835

View our white papers

FDA Releases Cybersecurity Guidance

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Siemens

Camstar Medical Device Suite, a leading manufacturing execution system (MES) for the medical device and diagnostics industry, is an industry-specific solution based on the Camstar Enterprise Platform from Siemens PLM Software.  It enables error-proof processing, paperless manufacturing, electronic device history records (eDHR), electronic batch records (eBR), and enterprise manufacturing best practices.  Camstar Medical Device Suite has a proven track record of helping emerging, midsize and global medical device and diagnostics organizations - regardless of size - achieve cost reductions and regulatory compliance while consistently producing high-quality products.

Contact: Chris Parsons, Senior Director of Marketing, Camstar Global Marketing, Siemens Product Lifecycle Management Software Inc. 

View our white papers

Global Ready at the Speed of Demand

The Essential Role of MES/MOM in Industry 4.0

With Camstar's MES, Terumo CVS increased productivity and output while reducing

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Cognizan

Cognizant's Life Sciences practice is committed to helping change millions of lives for the better by partnering with clients to build solutions to healthcare challenges, continually improve the way they do business, set the pace in clinical development, strengthen their regulatory infrastructure, and increase competitiveness. Cognizant serves 28 of the top 30 global pharmaceutical companies, 9 of the top 10 biotech companies, and 12 of the top 15 medical device companies.

Contact: Sriraman Nagajaran, Associate Vice President & SBU Head, Life Sciences

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Deloitte

Deloitte’s life sciences and health care industry group is composed of more than 7,300 professionals in over 90 countries. We understand the complexity of today’s life sciences industry, including the journey to redefine patient-centric care, innovate, and grow, and can help clients through the challenges that each part of the journey can bring. Our professionals are backed by a global organization whose tools, industry-wide experience, and knowledge are aligned to help companies see what’s in front of them and what’s ahead. Our team can pull together the resources and cross-discipline capabilities to help formulate the right strategy and turn it into reality.

Contact: Lynn Sherry, Senior Marketing Manager Life Sciences

View our white papers

Mobilizing MedTech for mHealth: Market trends and potential opportunities

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Evaluate

Evaluate is the trusted source for life science market intelligence and analysis with exclusive consensus forecasts to 2020. Our subscription services include EvaluatePharmaEvaluateClinical Trials and EvaluateMedTech. Evaluate Custom Services provides project-based analytical and data services. Our award-winning editorial team, EP Vantage, leverages our strategic analysis to cut through the noise, giving you daily opinion and insights. The Evaluate services enable the life science community to make sound business decisions about value and opportunity. For more information please visit www.evaluate.com

Twitter: @evaluatepharma@evaluatemedtech

Contact: Alan Raider, Director Strategic Accounts MedTech

Click here to access Evaluate’s AdvaMed members resources.

View our white papers

MedTech 2015 in Review

EvaluateMedTech World Preview 2015, Outlook to 2020

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Global Healthcare Exchange, LLC

Global Healthcare Exchange, LLC (GHX) drives costs out of healthcare with cloud-based supply chain management technology and services to help enable better patient care and savings by maximizing automation, efficiency, and accuracy of business processes. GHX offers healthcare providers and suppliers an open and neutral electronic trading exchange that delivers procurement and accounts payable automation, contract and inventory management, vendor credentialing and management, business intelligence, and other supply chain-related tools and services.

For more information, visit www.ghx.com and The Healthcare Hub.  

Contact:  Denise Odenkirk, AVP Supplier Sales and Services, 609.216.4512

View our white papers

Taking an Industry Leadership Position in UDI Adoption

Strategies for Healthcare Supply Chain Collaboration

Solving Pricing Alignment in Healthcare

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King & Spalding

Celebrating more than 125 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with 800 lawyers in 17 offices in the United States, Europe, the Middle East and Asia. The firm has handled matters in over 160 countries on six continents and is consistently recognized for the results it obtains, for uncompromising commitment to quality and for dedication to understanding the business and culture of its clients. King & Spalding was recently chosen by U.S. News & World Report and Best Lawyers as the "Law Firm of the Year" for FDA law and LMG Life Sciences selected the firm as one of the finalists for “Regulatory Firm of the Year” in 2015.

Contact: Mark Brown, Partner, 202.626.5443

View our client alerts

King & Spalding's FDA & Regulatory Client Alerts

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Korn Ferry

At Korn Ferry, we design, build, attract and ignite talent. Since our inception, clients have trusted us to help recruit world-class leadership. Today, we are a single source for leadership and talent consulting services to empower businesses and leaders to reach their goals. Our solutions range from executive recruitment and leadership development programs, to enterprise learning, succession planning and recruitment process outsourcing (RPO).

Visit http://www.kornferry.com for more information on Korn Ferry, and http://www.kornferryinstitute.com for thought leadership, intellectual property and research

Contact:  Richard M. Arons, Office Managing Director

View our white papers

The Seven CEOs: The essential purpose of succession management

The signposts: The unmistakable markers that identify high-potential leaders

Precision talent intelligence: The definitive four dimensions of leadership and talent

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L.E.K. Consulting

Latham & Watkins LLP is an international law firm with a global footprint of more than 2,400 lawyers in more than 30 offices. Latham’s award-winning practices throughout the life sciences industry guide clients through their most significant and cutting-edge legal challenges through a combination of in-depth industry knowledge, legal acumen and strategic business advice. The firm operates as a fully integrated ‘one firm’ firm, embodying a collaborative approach to client service and ensuring the firm’s clients have a legal team that understands the economic, regulatory and political climates in which they operate.

Contact: Stuart Kurlander, Partner

View our white papers

President Obama Signs the 21st Century Cures Act Into Law

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L.E.K. Consulting

L.E.K. Consulting is a global management consulting firm that uses deep industry expertise and rigorous analysis to help business leaders achieve practical results with real impact. We are uncompromising in our approach to helping clients consistently make better decisions, deliver improved business performance and create greater shareholder returns. The firm advises and supports global companies that are leaders in their industries — including the largest private and public sector organizations, private equity firms and emerging entrepreneurial businesses. Founded more than 30 years ago, L.E.K. employs more than 1,000 professionals across the Americas, Asia-Pacific and Europe. 

Contact: Megan DeNovellis, Marketing Coordinator

View our white papers

What’s Next for U.S. Healthcare Under Trump?

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MasterControl

MasterControl offers quality and compliance consulting services tailored for a company's compliance, regulatory, and quality needs for both customers and non-customers. For noncustomers, MasterControl consultants can provide assistance regardless of the electronic QMS solution used by the company, or even when it does not have quality systems in place. MasterControl thought leaders offer on-site workshops and coaching services on all core quality processes, including CAPA, audit management, risk management, supplier management, and document management.

Contact: info@mastercontrol.com, 866-747-8767

View our resources

Demo: MasterControl Quality Management System (QMS) Overview

Quality Management Toolkit

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Medmarc

Industry specific insurance and related risk management solutions

Created in 1979 by the healthcare technology industry, Medmarc’s purpose is to be the superior provider of liability insurance and related risk management solutions and to support the development, testing and delivery of medical products that save lives and improve the quality of life. Through collaboration with our parent company, ProAssurance, and our clinical trial industry experts, we provide a single source of innovative healthcare liability insurance solutions to the life sciences companies we serve.  From ideas and prototypes to the reality of commercialization and success – We can Meet Your Changing Needs. Call me to discuss the cost of insurance coverage, what coverages are needed and when for your business plan. 

Contact: George Ayd, (703) 652-1309

View our white papers

UDI Fundamentals, Ask an Expert

What are the best practices for dealing with FDA inspections?, Ask an Expert   

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Norton Rose Fulbright

Norton Rose Fulbright is a global law firm. We provide the world’s pre-eminent corporations and financial institutions with a full business law service. We have more than 3800 lawyers and other legal staff based in more than 50 cities across Europe, the United States, Canada, Latin America, Asia, Australia, Africa, the Middle East and Central Asia.

Recognized for our industry focus, we are strong across all the key industry sectors: financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and life sciences and healthcare.

Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.

Norton Rose Fulbright US LLP, Norton Rose Fulbright LLP, Norton Rose Fulbright Australia, Norton Rose Fulbright Canada LLP and Norton Rose Fulbright South Africa Inc are separate legal entities and all of them are members of Norton Rose Fulbright Verein, a Swiss verein. Norton Rose Fulbright Verein helps coordinate the activities of the members but does not itself provide legal services to clients.

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Novasyte

Novasyte partners with medical device and diagnostic companies to deliver flexible service solutions to their customers.  Providing contract sales, clinical and technical support teams, Novasyte brings market knowledge and experience to tackle many different challenges. Areas of expertise include, case coverage, clinical in-servicing, product launches, phone support, inside sales and recall management.  Custom Tableau analytics dashboards, deliver real-time effectiveness on a granular level to maximize visibility in order to achieve strategic success. 

Contact: Tim Gleeson, Chief Executive Officer, 949.214.5900

View our case studies

After Hours Phone Support for New Product Launch

Aftercare Patient Support Program 

Contract Sales Success Story

Increased Selling Time

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Pilgrim Quality Solutions         

Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries. For more than 20 years, our solutions have automated thousands of processes that ensure the quality of life’s most important products. Product quality and patient safety increase while risks decline. Our on-premise and cloud technologies reflect quality industry standards and include electronic signatures, audit trails and validation packs - helping customers more easily achieve compliance and pass regulatory audits.

Contact:  Sandy Carson Hessen, Marketing Communications Manager

View our white papers

Six Strategies for Internal Audit Success: An Essential Guide for Internal Auditors   

7 Tips for Transitioning to Electronic Medical Device Reporting

Leverage CAPA Best Practices to Build a Culture of Quality    

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PwC

PwC’s Pharmaceuticals and Life Sciences Industry Group is dedicated to delivering effective solutions to the complex strategic, operational, and financial challenges facing pharmaceutical, biotechnology, and medical device companies. We provide industry-focused assurance, tax, and advisory services to build public trust and enhance value for our clients and their stakeholders. More than 195,000 people in 157 countries across the PwC global network of firms share their thinking, experience, and solutions to develop fresh perspectives and practical advice.

Contact: Meredith Berger, PwC Pharma/LS Marketing Manager

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Quintiles

QuintilesIMS is a leading integrated information and technology-enabled healthcare service provider dedicated to helping clients improve their clinical, scientific and commercial results conducting operations in more than 100 countries. Companies seeking to improve real-world patient outcomes and enhanced clinical trial outsourcing, care provision and access can leverage QuintilesIMS's broad range of healthcare solutions to drive new insights and approaches.  Protecting individual patient privacy, QuintilesIMS uses healthcare data to deliver critical, real-world disease and treatment insights.

View our latest thinking and articles

Quintiles blog

Quintiles Articles

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Reed Smith

Reed Smith’s global Life Sciences Health Industry Group is multidisciplinary, involving the skills and experience of a core practice group of nearly 200 attorneys devoted entirely to the life sciences and health care fields. We have represented virtually every type of enterprise connected with the life sciences health industry—including many of the world’s largest pharmaceutical and medical device manufacturers, and all types of health care providers. Our work for device clients includes matters involving FDA regulatory counseling; reimbursement issues for new and established medical technology; contract pricing strategies; investigations; health care fraud and abuse compliance; and intellectual property issues.  We were honored to assist AdvaMed in matters involving the Association’s Code of Ethics with Health Care Professionals, and the CMS Open Payments (Sunshine) legislation and regulations.

Contact:  Elizabeth B. Carder-Thompson, Partner 

View our white papers

Analysis of CMS' Proposed Medicare "Comprehensive Care for Joint Replacement" Model

3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles

Cybersecurity for Medical Devices: A Risk Mitigation Checklist for In-House Counsel

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R&Q

R&Q provides integrated quality and regulatory consulting solutions to medical device companies. We support the life-cycle of medical devices from conceptual development through post-market surveillance, providing solutions that accelerate the success of medical device companies and improve people’s lives.

Contact: Stephen Biernacki, Senior Marketing Specialist

View our white papers

10 Tips: Warning Letters

Managing An Adverse FDA Inspection: Practical Considerations for Avoiding Regulatory Escalation

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Ropes & Gray

Ropes & Gray's global life sciences group is one of the leading life sciences practices in the nation and worldwide.  We represent a broad range of emerging, midsize and Fortune 500 medical device, pharmaceutical, biotechnology, consumer health care and food companies on cutting-edge matters, as well as the financial institutions that invest in the industry.  Our multidisciplinary team of lawyers and technical specialists – with deep knowledge of FDA regulatory, government enforcement, intellectual property, private equity, securities and corporate law – work together in a coordinated fashion to provide the knowledge and experience to resolve virtually any legal problem facing life sciences companies all around the world.  Our work covers a full range of legal areas, including M&A, licensing, private financings, and public offerings; FDA regulation and life sciences-related public policy; patent due diligence, prosecution and litigation; research and health care compliance; and internal investigations and government enforcement defense.

Contact:  Margie Stebbins, Practice Development Manager, Life Sciences

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SAP

As the market leader in enterprise application software, SAP is at the center of today’s business and technology revolution. Our innovations enable more than 291,000 customers worldwide to work together more efficiently and use business insight more effectively.

SAP helps organizations of all sizes and industries overcome the complexities that plague our businesses, our jobs, and our lives. With Run Simple as our operating principle, SAP’s nearly 75,000 employees focus on a singular purpose that inspires us every day: To help the world run better and improve people’s lives.

Contact:  Susan Rafizadeh, Director, Global Industry Cloud Marketing Life Sciences

View our white papers & articles

Bloomberg Businessweek Case Study CareFusion: "Real-Time Business Leads to Healthy Performance"

Bloomberg Businessweek Case Study: Varian Medical Systems: Improving Performance and Processes Behind the Scenes

Medtronic: Keeping Pace with Chronical Medical Conditions

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SalesForce4Hire

SalesForce4Hire is a leading commercialization company with over a decade of experience helping medtech companies offset risk, manage costs and achieve dramatic results through non-traditional approaches of product commercialization.  SalesForce4Hire turns your healthcare challenges into measurable results. We work with Emerging, Fortune 500, International companies and Investors that back them.

Contact: Nineveh Spaulding, Marketing Manager

View our case studies and white papers

Reversing Seasonal Product Share Loss in the Hospital Lab Market

Begin Your Path to Commercialization Success by Accessing Our Whiteboard Planning Tool

Launching a Disruptive Technology into the Global Life Science Research Market

Launching Medical Device Product and Positioning Company for Acquisition

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Sidley Austin LLP

Sidley Austin LLP is a premier law firm providing a broad range of services to meet the needs of large and small businesses across a multitude of industries, financial institutions, governments and individuals. Our Global Life Sciences practice counsels clients across three continents on the spectrum of issues manufacturers face throughout the life cycle of their products. Our team of more than 300 practitioners assists with matters involving all key areas of law, including: food, drug and medical device regulatory; compliance, enforcement and litigation; intellectual property; antitrust/competition; corporate and technology transactions; private equity; FCPA/anti-corruption; government strategies; privacy, data security and information law.

Contact: Rebecca K. Wood, Partner, 202.736.8663

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Sparta Systems

Sparta Systems, an industry pioneer and leading provider of enterprise quality management software (EQMS) solutions, enables businesses to safely and efficiently deliver their products to market. Its TrackWise® EQMS, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in New Jersey and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer products markets.

Contact: Colleen Nugent, Product Marketing Manager

View our white papers and eBooks

Using Automation to Gain Efficiencies with Product Registration Tracking 

Turning Medical Device Complaints into Quality Management Intelligence 

Five Steps to UDI Compliance Through EQMS 

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UL

UL provides comprehensive services to support medical and IVD companies with global regulatory submissions.  Our local services include integrated systems registrations for ISO 13485, Canada CMDCAS, European Notified Body under MDD and IVDD Brazil – INMETRO and Risk Management ISO 14971.  Our experienced engineers provide safety assessments to IEC 60601, IEC 61010, Home use devices, software, cybersecurity and CB Scheme.  Our Human Factors Engineering experts provide usability design support and validation testing.  Our pre-clinical and clinical experts provide testing and validation for sterility, shelf life, biocompatibility, CRO ISO14155 and more.  Our technical consultants provide technical documentation, regulatory submission support, mock audits, supply chain services, regulatory learning management systems and more.  

Contact: Jefferson Barr, UL Eduneering, 609.627.5391

View our white papers

A Playbook for FCPA and Anti-Bribery Compliance Training & Communication

Managing the Risks of Third Party Intermediaries

A Quality and Compliance Training Road Map for Emerging FDA-Regulated Companies

A Tale of Two C’s: From Compliance to Competency

Major Revisions to ISO 13485:2016

Medical Device Regulations of Taiwan

What's Involved in an FDA Inspection

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