Pharmaceutical and Medical Device Compliance

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Gold Grantors

Deloitte

We are committed to helping our clients solve their most complex issues. Deloitte Risk and Financial Advisory professionals help our clients view change as opportunity for innovation and strategic movement. From threats that require immediate mitigation, to operational uncertainties, and everything in between, we focus on the full continuum and constantly innovate to see risk in its many dimensions. At Deloitte, we help our clients lead, navigate, and disrupt through complexities, to create a strategic advantage and accelerate performance.

Silver Grantors

EY

Tighter competition, regulatory scrutiny and tough enforcement heighten the risk of litigation and non-compliance. In the life sciences industry, compliance issues and risk factors need to be addressed at every turn, from research and development to marketing strategies and supply chain integrity, while the scrutiny of regulators and customers alike is increasing and rapidly changing. Our professionals understand the complex issues facing pharmaceutical, biotechnology and medical device companies. We have established experience helping companies evaluate and manage those aspects of their businesses that pose the greatest potential risks. Our dedicated team includes CPAs, certified fraud examiners, licensed pharmacists, former pharmaceutical executives, ethics and compliance officers as well as government auditors, investigators and prosecutors. For more information, please contact Kathleen Meriwether, Americas Leader, Life Sciences Forensic and Integrity Services, at 215-448-5607 or kathleen.meriwether@ey.com

Grant Thornton

The rapidly evolving health care needs of our population, coupled with the development of new markets, present limitless opportunities and an evolving set of challenges for life sciences companies. Whether your company concentrates on pharmaceuticals, medical devices, bioengineering or research, Grant Thornton’s Life Sciences Practice can help. Our comprehensive range of advisory, audit and tax services can help your company achieve a real competitive advantage, now and into the future.

Polaris

Polaris, IQVIA Global Compliance, is the world’s leading healthcare compliance software and consulting firm, providing innovative solutions to Life Sciences companies. Our services range from best-in-class compliance software to expert consulting, planning and strategic guidance from the industry’s leading compliance authorities. Polaris also offers competitive data analytics and end-to-end managed services. Polaris is headquartered in New York City, with worldwide offices in Amsterdam, Boston, Hong Kong, New Brunswick, Paris and San Francisco. Since 2001, the world’s most recognized pharmaceutical, biotech and medical device companies have relied on Polaris as their trusted life sciences compliance solutions partner.

PwC

PwC’s Pharmaceutical and Life Sciences Industry Group helps organizations – from those who develop drugs to those who manufacture medical devices – better connect to consumer needs to develop and deliver the treatments of tomorrow. We work with clients to uncover their most valuable strengths, identify complementary partnerships and keep up with the latest advances in technology, so they can better compete in an evolving health market and improve cost-efficiency and profitability.

Bronze Grantors

AlixPartners

AlixPartners is a results-driven global consulting firm that specializes in helping businesses respond quickly and decisively to their most critical challenges – from urgent performance improvement to complex restructuring, from risk mitigation to accelerated transformation. These are the moments when everything is on the line – a sudden shift in the market, an unexpected performance decline, a time-sensitive deal, a fork-in-the-road decision. We stand shoulder to shoulder with our clients until the job is done, and only measure our success in terms of the results we deliver. We partner with you to make the right decisions and take the right actions. And we are right by your side. When it really matters.

Arnold & Porter

Arnold & Porter, an 1000+ lawyer firm with offices in the US, Europe and Asia, 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 in developing, implementing and refining global compliance programs that address regulatory and enforcement risks confronted at each stage of product research and development, manufacturing, marketing and distribution. We regularly advise companies in matters raising complex compliance issues, developing practical solutions to the challenges associated with conducting clinical trials in jurisdictions with varying healthcare systems, the complexities and risks of pharmaceutical supply chains, interactions with physician and patient populations, managing co-development and co-promotion arrangements, and outsourcing of functions in areas such as research, pharmacovigilance and manufacturing. We also vigorously defend our clients in a broad range of investigations and enforcement matters.

Baker McKenzie

Our lawyers have acted as trusted advisers to the world’s largest healthcare companies for more than half a century. Among the first firms to provide comprehensive industry advice — covering biopharmaceuticals, medical devices, and healthcare services — we have broad experience and a sophisticated understanding of the global life sciences market that few can match. We help healthcare companies soundly navigate intensifying legal and commercial risks, realize opportunities for expansion and growth, and stay ahead of the innovation curve. Our international network spans 47 countries, including the largest healthcare markets in the world. Many of our practices — including M&A, Tax, Compliance, Healthcare Regulatory, Employment, Intellectual Property, and Dispute Resolution — are ranked among the world’s leading. Our lawyers have developed a depth of knowledge in the industry in respect of various market players including manufacturers, distributors, research institutions, clinical trial bases and health and regulatory authorities.

BRG Healthcare

Berkeley Research Group is a leading global strategic advisory and expert consulting firm that provides independent advice, data analytics, valuation, authoritative studies, expert testimony, investigations, transaction advisory, restructuring services, and regulatory and dispute consulting to medical technology and pharmaceutical companies, providers, insurers, and counsel. BRG healthcare corporate compliance and risk management professionals have experience with C-suite corporate compliance, government enforcement, and advanced transactional data analysis; and a strong understanding of the operational, technical, and legal challenges that our clients must address. BRG professionals provide innovative, data-driven, cost-effective, and practical solutions to enhance operational efficiency, inform business decision making, and address and remediate key legal risks proactively. An important building block is our understanding of how healthcare organizations operate and interact with stakeholders in the healthcare continuum. Our reports and findings have been used to resolve critical business, regulatory, and legal challenges.

Cooley, LLP

For over 40 years, lawyers in Cooley’s Life Sciences practice have played an instrumental role in the growth of many of the industry’s leading life sciences companies. Our client base includes hundreds of public and private companies, based in the United States and abroad, and spans the full spectrum of industry sectors including pharmaceuticals, R&D, therapeutics, drug delivery, drug formulation, and medical devices and technologies. We deliver an unparalleled combination of innovative legal expertise, deep industry knowledge and practical understanding of our clients’ business needs. Cooley is counsel to more than 1400 public and private life sciences companies across the globe and serve as counsel to more than 50% of the companies on the NASDAQ Biotechnology Index. Cooley has a leading group of health care and life sciences regulatory lawyers who understand the challenges and opportunities facing the industry. In an environment filled with an increasing number of evolving laws and regulations, our team has the depth of experience necessary to navigate the ever changing rules of the marketplace for providers, manufacturers, suppliers, payors, technology companies and investors in this space. Cooley has 900 lawyers across 12 offices in the United States, China and Europe. We have an entrepreneurial spirit, deep substantive experience, and a commitment to solving clients’ most challenging legal matters.

Corporate Research and Investigations Limited

3PRM-Certified® is an Accredited ISO 37001:2016 Anti-Bribery Management System Certification program of CRI Group’s Anti-Bribery and Anti-Corruption (ABAC®) Centre of Excellence, providing each client with widespread bribery and third-party risk assessment, examination and evaluation of the organization’s adequacy of the anti-bribery policies and procedures worldwide. The program helps ensure that the organization has implemented an adequate management system, processes, and controls which prevents, detects and responded to bribery and complies with anti-bribery laws, in a way that applies to both the organization’s operations and it’s outside affiliated business partners (such as agents, consultants, suppliers, distributors, and other third-parties). CRI Group’s Anti-Bribery and Anti-Corruption (ABAC®) Centre of Excellence is the very first Accredited Certification Body for the scope of ISO 37001:2016 Anti-Bribery Management System with most substantial jurisdictional coverage worldwide and having diversified industry sector experts, analysts, compliance, ethics, and legal professionals and not just traditional ISO auditors.

Covington

Covington & Burling LLP offers one of the largest and most comprehensive life sciences practices in the world. We represent biotech, pharmaceutical and medical device companies in the U.S., Europe, Asia and other major and emerging markets. Our lawyers are adept at seamlessly integrating the firm’s strong regulatory, corporate, investigations, litigation, policy, competition, and intellectual property practices, among others, to meet the specialized needs of life sciences companies around the world. Our team features numerous alumni of the FDA, HHS, and other key regulatory agencies in the U.S., Europe, and Asia, as well as two former general counsels of pharmaceutical companies. We are the only firm recognized by Chambers as a "Band 1" firm for Life Sciences across their U.S., UK, Europe, China and Global surveys.

Cutting Edge Information (CEI)

Cutting Edge Information (CEI) is a Market Research Company that specializes in collecting and analyzing global FMV data. To CEI, collecting and analyzing FMV data is not an ancillary function, but our primary function. Our data approach has been accepted by the majority of the largest pharmaceutical companies, as it reduces regulatory and compliance risk, is customizable, increases HCP acceptance of compensation fairness, and can be delivered in almost any format to meet existing FMV system needs. Our FMV customers currently include over 100 companies, and we are the provider of choice to the world’s largest pharmaceutical companies. We pride ourselves on exceptional, personalized customer service, an assertion supported by the endorsements from our clients. We are the FMV data provider of choice for the pharmaceutical industry.

Davis Wright Tremaine

Those of us in the Davis Wright Tremaine health care practice group devote nearly all of our time to industry-specific matters. This allows us to develop niche practices within the field that serve needs unique to the health care market. We also understand the business issues and regulatory developments that affect health care delivery and compliance, and as a unified team we can match the attorney with the niche expertise that best addresses client needs.

Dovetail Consulting Group

Dovetail Consulting Group combines relevant industry experience with consulting discipline and structure. We bring our experts to engagements and will only accept work to which we can dedicate our full attention. Our focused approach enables us to design and implement the right-sized solution for each client’s needs. Services provided to compliance and risk departments in the pharmaceutical, biotechnology, and medical device industries include: - Long-term functional strategy and vision - Annual strategic and operational planning - Interim staffing and management solutions - Board of Director expert services and training - CIA readiness assessment and remediation - Custom program builds for emerging companies - Policy, procedure, and process development - Monitoring and auditing strategy, planning, and design - Merger and acquisition support: target review, transaction support, and integration assistance - Enterprise risk assessments and management solutions - Compliance risk assessments - Patient support program assessments - Compliance culture and change management services - Programmatic compliance gap assessment

G&M Health

G&M Health, LLC is a health and life-science service company offering compliance management services, computer validation, project management, audits & assessments, aggregate spend services, Corporate Integrity Agreement (CIA) management, hospital credentialing, jurisdiction licensing, training and MLR Committee support services. G&M was founded by recognized legal and regulatory compliance experts in the healthcare industry, who have worked with and/or advised over 100 pharmaceutical and biotech companies over the last 20 years. Our mission is to be the premier provider of innovative, quality, efficient and compliance-oriented solutions for the healthcare industry.

Helio Health Group

Helio Health Group specializes in providing consulting and data science services to clients within the life sciences industry. Helio works with clients across all stages of development from established global pharmaceutical companies to new, burgeoning gene therapy companies. Helio works with key stakeholders to provide strategic and operational compliance insights relating to commercial, medical, and patient services while utilizing industry consulting experience coupled with advanced analytical techniques. In addition, Helio frequently conducts gap assessments to analyze the current state of our client’s compliance operations including (but not limited to) a thorough review of process designs, system configuration, workflows, procedures, etc. Upon completion of such an assessment, Helio develops business/technical requirements and roadmaps to provide guidance on how to augment and operationalize the company’s compliance and strategic initiatives. Helio also implements the desired program enhancements and serves as a Project Management Office (PMO) and strategic advisor throughout the implementation. Other areas of compliance assistance include monitoring and auditing various functions and Transparency strategy, validation and reporting services.

Hogan Lovells

Navigating complexities in the life sciences and health care industries is no easy task. Successfully competing in the space requires a partner with a holistic, collaborative approach and a global perspective. It calls for a strategy informed by asking the right questions and rooted in identifying creative solutions to your unique challenges. For life sciences innovators of all sizes, anywhere in the world, Hogan Lovells is that partner — from cutting-edge start-ups and boutique venture funds to world-renowned research institutions and health systems to global biopharmaceutical conglomerates. Your business and your challenges don’t stop for oceans or disappear at national borders. Neither does Hogan Lovells. Our team of 500 life sciences and health care lawyers is located around the world but operates as if everyone is working from the same office — providing a seamless experience everywhere you do business. And no matter the challenge — from creation to commercialization of a life-saving therapy, regulatory compliance to an international patent dispute, the formation of a strategic alliance to a complex, global merger — we’ve been there before and we understand how to prepare you for what happens next, helping you to anticipate risks and address future issues before they arise.

King & Spalding

Celebrating more than 130 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 1000 lawyers in 20 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 Law360 and U.S. News & World Report 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."

Navigant

Navigant Consulting, Inc. (NYSE: NCI) is a specialized, global professional services firm that helps clients take control of their future. Our life sciences and healthcare consultants help you navigate the complex regulatory environment of Pharmaceutical, Biotech, Medical Device and Diagnostics industries, we apply our deep industry knowledge, technical expertise, and strategic approach to offer solutions and deliver powerful results. From the synthesis of highly complex transactions, rules, regulations, data, documents and business practices to bring meaningful value to the co-development of a dispute, regulatory, compliance or investigation strategy and execution, we help clients help clients build, manage, and protect their business interests.

Paul Hastings

Paul Hastings provides innovative compliance and legal solutions to many of the world’s top pharmaceutical and life sciences companies, large and small, in markets across Asia, Europe, Latin America, and the United States. We offer a complete portfolio of services to support our clients’ complex, often mission-critical needs–from structuring transactions, to protecting critical intellectual property, to resolving complicated U.S. healthcare and global anti-corruption enforcement matters, to providing the savvy compliance and legal counsel that keeps business moving forward. Paul Hastings has grown steadily and strategically along with our clients across global markets in the critical pharmaceutical and life sciences sector. We have a significant and strategic presence across Europe, and were one of the first U.S. law firms to establish a presence in Asia, where we continue to be a leader in the region, and have significantly expanded our support for clients in Brazil, out of our new São Paulo office, and other emerging markets of Latin America.

Potomac River Partners

Potomac River Partners is a specialized management consulting firm focused on compliance for the life science industry. Our team serves as an extension of your compliance program. We are experts on the laws and regulations, but we don’t provide purely academic or legalistic recommendations. Instead, we listen to your objectives and then implement real change that reduces risk for your organization in a smart, efficient way. Our core service areas include: • Policies & Procedures • Training & Communication • Auditing & Monitoring • Aggregate Spend

Ropes & Gray

We routinely advise clients on developing effective compliance policies to avoid the debilitating effects of government investigations, regulatory enforcement actions, or other litigation based on alleged noncompliance with applicable laws and regulations. Our command of FDA regulatory, health care compliance, research compliance and global anti-corruption issues is critical for clients operating in these highly regulated industries. For companies that are the subject of government investigations, our understanding of the enforcement landscape enables us to defend complex proceedings involving simultaneous civil, criminal and administrative actions. This depth and breadth of experience, coupled with our interdisciplinary team of leading regulatory, compliance, litigation, government enforcement, and anti-corruption attorneys, has established us as the “go-to” firm when it comes to avoiding and successfully resolving litigation and government investigations. Our integrated practice, including our corporate transactional department, also allows clients to eliminate the inefficiencies associated with hiring multiple, independent firms.

SAI Global

SAI Global helps organizations proactively manage risk to create trust and achieve business excellence, growth, and sustainability. Our integrated risk management solutions are a combination of leading capabilities, services and advisory offerings that operate across the entire risk lifecycle allowing businesses to focus elsewhere. Together, these tools and knowledge enable clients to develop a holistic, integrated view of risk. We have global reach with locations across Europe, the Middle East, Africa, the Americas, Asia and the Pacific.

Sidley

Sidley’s global life sciences practice comprises a team of multidisciplinary lawyers with a deep understanding of the issues innovators face—from the science and technology to the business realities. We tackle the hardest problems and offer solutions that account for not only the direct risk but also the substantial relational capital at stake. Harnessing our breadth of experience, we represent prominent pharmaceutical, biotechnology, medical device, dietary supplements and food clients on a range of regulatory, compliance and enforcement issues. Strong advocacy on behalf of our clients consistently earns our team acknowledgement from industry publications. This includes first-tier national rankings in Biotechnology Law, FDA Law and Healthcare Law in the U.S. News — Best Lawyers® “Best Law Firms” rankings for the eighth consecutive year, and each year since the survey’s inception. In addition, our service and responsiveness earned us recognition in the BTI Industry Power Rankings as a "Most Recommended Law Firm in the Pharmaceutical Industry."

Skadden

With approximately 1,700 attorneys in 22 offices in the Americas, Europe and Asia Pacific, Skadden serves a broad range of clients in all sectors of the health care industry, including pharmaceuticals and medical technology. The firm represents pharmaceutical and medical technology clients at every stage of a company’s development, from initial public offering to global M&A and corporate finance; and all manner of litigation and regulatory matters, including government investigations, mass torts and product liability litigation, intellectual property counseling and patent litigation, and FDA and health care compliance. Skadden has assisted many companies in developing and implementing global anti-bribery and anti-corruption compliance programs and represented numerous companies in related government investigations.

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