Regulatory and Compliance

Entities regulated by the Food and Drug Administration (FDA)—including manufacturers, wholesalers, distributors, 3PLs, and retailers—and their investors require the legal insight and business acumen of an FDA Regulatory and Compliance practice with a breadth of experience across the development, manufacturing, distribution, and marketing of FDA-regulated products. That is the Sidley FDA Practice—we partner with our life sciences and medtech clients to provide practical, business, and risk-focused strategic advice on bread-and-butter issues as well as the novel, cutting edge, and bet-the-company issues that arise in a scientifically and technologically changing world.

Our team includes lawyers and compliance advisors with experience in senior roles at FDA, the Department of Health and Human Services, and other federal agencies and legislative bodies, as well as with advanced technical degrees. Our practice is experienced and wide-ranging, and we have deep knowledge across the areas FDA regulates including pharmaceuticals, biologics, vaccines, gene and cell therapies, devices, combination products, diagnostics, digital health, AI, software, animal health, OTC drugs, foods, infant formula, dietary supplements, and cosmetics.

Sidley’s FDA practice is nationally recognized for its excellence and consistently earns top-tier rankings in leading legal directories, including Chambers USA, LMG Life Sciences, and U.S. News – Best Lawyers. The team has repeatedly been honored as a standout in the field, receiving the “Law Firm of the Year” award in FDA Law from U.S. News – Best Lawyers in 2020, 2022, and 2024.

Our areas of focus include:

• Evaluation of Premarket Regulatory Strategies: We help clients navigate the best pathways to get their FDA-regulated products to market, in light of product classification considerations and development and clinical trial issues. We guide our clients through important agency interactions (e.g., FDA and Advisory Committee meetings) and help ensure that communications with the agency are strategically aligned.
• Market Exclusivities: We regularly advise on Hatch-Waxman market exclusivity, as well as obtaining and protecting orphan drug and pediatric market exclusivity.
• Labeling, Advertising, and Promotion: We counsel clients on labeling, advertising, and promotion issues, considering FDA, FTC, and NAD requirements and precedent. We address marketing practices for our clients—conducting comprehensive label reviews, assessing claims and claim substantiation, counseling on “off-label” communications, as well as the complexities and nuances of internet and social media promotion. We track FDA Warning Letters, Courtesy Letters, False Claims Act matters, and other enforcement actions to keep our fingers on the pulse of areas of heightened scrutiny and risk.
• Compliance and Enforcement: We advise companies on all aspects of “GxP” compliance—including Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR), Good Clinical Practice (GCP), Good Laboratory Practice (GCP), and Good Pharmacovigilance Practice (GVP)—as well as data integrity, supply chain/distribution, and safety/pharmacovigilance issues. Our team conducts internal investigations and risk assessments, guides clients in implementing enterprise-wide compliance programs and develops strategic responses to 483s, Warning Letters, and Untitled Letters. We help clients prepare for inspections, provide support during inspections, and assist in arranging and preparing for Regulatory Meetings with FDA, with additional support from our technical experts, who include former FDA inspectors.
• Advocacy and Contentious Proceedings: Unique among law firms, Sidley’s FDA team handles a broad range of contentious and non-contentious proceedings involving FDA, advocating on behalf of clients to resolve disputes with the agency. This work ranges from agency legal and regulatory meetings to Citizen Petitions, Advisory Committee meetings, informal and formal agency appeals and dispute resolution, and hearings. We address complex and often unprecedented legal, regulatory, public health, and policy questions presented in clinical holds, refusals to file (RTF), complete response letters (CRL), approval and withdrawal determinations, rulemaking, guidance documents, and other contexts. Where it becomes necessary, our work extends to judicial review of agency proceedings and related litigation.
• Life Science Transactions: We partner with our Life Science colleagues on the full range of corporate transactions, preparing companies for transaction-related scrutiny, conducting diligence, structuring sound contingent value rights (CVR) and milestone provisions, and helping with post-transaction integration activities. We assess product classification, marketing pathway, supply chain, regulatory exclusivity, compliance history, enforcement potential, and numerous other issues that may impact transaction value. We also apply our experience and deep understanding of the risks and opportunities facing all Life Science companies in an evolving regulatory environment, not only to help evaluate regulatory risk but also to help enhance enterprise value.
• Global Life Sciences Practice: We are fully integrated into Sidley’s pioneering Global Life Sciences practice of over 300 lawyers worldwide. We work seamlessly across multiple legal practice areas and jurisdictions, cross-functionally tackling the issues faced by our life sciences clients in the United States and across the globe, including Europe, the UK, Switzerland, and Asia Pacific.

Contacts

Rebecca Wood
Raj Pai
Torrey Cope

Learn more about our Food, Drug and Medical Device practice.

In a world of intensifying oversight and divergent regulatory regimes, healthcare and life sciences companies must navigate regulatory requirements and compliance across continents. Sidley’s interdisciplinary Global Life Sciences (GLS) platform delivers actionable, sector-specific regulatory counsel grounded in deep industry experience and global reach. We support clients across every stage of the product and provider lifecycle, helping them mitigate risk, access markets, and stay ahead of enforcement trends.

Sidley’s GLS Healthcare Regulatory and Compliance team delivers:

• Mitigating Fraud and Abuse Risk: We advise clients on structuring financial arrangements, pricing, and reimbursement strategies aligned with global anti-bribery, anti-kickback, and self-referral laws. Drawing on frameworks like the U.S. False Claims Act, the UK Bribery Act, and EU transparency rules, we design compliance programs that withstand enforcement scrutiny and support integration, internal investigations, and voluntary disclosures.
• Aligning Digital Innovation with Global Data Standards: We guide clients through regulatory, privacy, and cybersecurity obligations tied to telemedicine, AI-enabled diagnostics, and cross-border data use. Our counsel spans HIPAA, GDPR, APAC data regimes, and emerging standards—helping clients innovate while minimizing digital health risk.
• Navigating Payor Systems Across Markets: Sidley advises on reimbursement strategy across public and private payor systems in the U.S., EU, UK, Asia-Pacific, and Latin America. We support health technology assessment (HTA) engagement, pricing and access models, and value-based reimbursement frameworks, helping clients secure market access and shape evolving policies.
• Managing Regulatory Strategy Across the Product Lifecyle: We counsel clients throughout the lifecycle of pharmaceuticals, biologics, and medical devices—covering pricing, distribution, promotional compliance, personal services arrangements, and post-market obligations. Our work spans global product registration, market entry, and post-launch oversight.
• Supporting Compliance in Advanced Diagnostics: Sidley advises high-complexity and specialty labs on global compliance with quality standards, LDT regulation, ISO and CLIA certification, and AI-driven diagnostics. We help clients navigate scrutiny, structure services, and comply with reimbursement and privacy laws in precision medicine.
• Navigating Global Licensing and Accreditation Frameworks: We support clients through licensure, accreditation, and certification worldwide—including change-of-ownership, facility credentialing, and regulatory enrollment. Our team ensures operational readiness across traditional, digital-first, and cross-border care models.
• Ensuring Global Clinical Trial Compliance: Sidley advises sponsors and CROs on multinational clinical research across FDA, EMA, MHRA, and Asia-Pacific frameworks. We guide trial authorization, site management, data governance, and reimbursement for investigational use, with a focus on compliance in early-phase and high-risk studies.

Contact
Meena Datta

Learn more about our Healthcare practice.

Current Good Manufacturing Practice (GMP) compliance—and regulatory compliance more broadly—is more important than ever. Advances in drug development and drug manufacturing technologies continue to stretch and challenge the existing regulatory framework. At the same time, the broad statutory authority granted to regulators, coupled with the array of regulatory and enforcement tools available to regulators, necessitates a strategic, proactive approach to identifying and addressing potential compliance issues. Sidley’s market-leading GMP team has led, supported, and successfully resolved critical compliance matters for companies of all sizes, from start-ups to Fortune 10 companies. These matters range from resolving significant internal compliance matters, FDA 483s, and Warning Letters, to helping some of the largest pharmaceutical and medical device companies in the world address application approvability issues due to quality and facility deficiencies.

Members of our dedicated GMP team include former U.S. Food and Drug Administration (FDA) lawyers, government prosecutors, and regulatory compliance specialists, including former FDA inspectors. Our extensive capabilities, combined with a long history of engaging FDA directly on behalf of our clients, set us apart in our ability to advise our clients on identifying and mitigating risk and achieving swift resolution of pending matters.

We represent numerous clients with complicated regulatory histories. We work closely with manufacturing sites to develop action plans with effective corrective and preventative measures in response to a variety of product-related investigations. In addition, our lawyers have significant experience conducting whistleblower and internal compliance investigations related to GMP compliance issues, as well as managing related government investigations by FDA, the Department of Health and Human Services, and the Department of Justice.

Supported by Sidley’s highly ranked government investigations and litigation practices, our team is capable of continuing representation until the resolution of any action.

Our value-added services include:

• Analyzing manufacturing sites and corporate functions for GMP compliance, including aseptic processing, combination products, sterile and other high-risk devices, post-marketing surveillance, and complaint handling;
• Performing gap analyses and developing GMP work plans;
• Training personnel, from the site level to the executive suite, on GMP enforcement activity and best practices;
• Assisting with inspection readiness activities, including the development of storyboards for complex issues, as well as providing support for and conducting sessions to help subject matter experts prepare;
• Advising on recalls, supplier management, and safety reporting, with a focus on compliance with medical device reporting (MDR) and adverse drug event (ADE) requirements;
• Conducting discrepancy, non-conformance, deviation, corrective and preventive action (CAPA), and product impact investigations with detailed root cause analysis;
• Engaging with the FDA and other agencies on behalf of a firm for previous or upcoming inspections, as well as with regard to ongoing compliance commitments;
• Supporting responses to FDA 483 inspectional observations, Warning Letters, and other government inquiries;
• Performing data integrity and documentation practices investigations;
• Advising companies on identifying third-party expert consultants and compliance action plans, and supporting such activities under the attorney-client privilege; and
• Assisting with issues related to supply chain compliance, including on implementation of systems to meet obligations under the Drug Supply Chain Security Act.

Our network of offices and international reach allow us to respond promptly to government inspections and enforcement actions and to coordinate company actions plans and communications with regulatory authorities and the press worldwide. We have worked with manufacturing sites in a number of countries:

Argentina Australia Austria Belgium Canada China Croatia Denmark England Finland France Germany

India Ireland Italy Japan Mexico Singapore South Korea Spain Sweden Switzerland Thailand United States, including Puerto Rico

Contacts

Raj Pai
Jim Johnson
Christopher Fanelli
Arif Noorani

Learn more about our Food, Drug and Medical Device practice.

Drug prices have become front-page news around the world, leading to blunt criticisms of the pharmaceutical and biologic industries. These criticisms, which all too often fail to recognize the value of the therapies, are fueling a heated policy debate and can have major legal implications for the pharmaceutical and biologics industry. Lawyers and policy advisors from Sidley’s Global Life Sciences team are at the center of the discussion. We are closely following the developments as they happen and sharing our knowledge about this rapidly evolving issue. Through new updates, client alerts, events and speaking engagements, we analyze drug pricing policy and legal developments impacting pharmaceutical and biologics manufacturers in the United States and abroad.

Contacts
Meena Datta
Trevor Wear

Learn more about our Global Drug Pricing practice.

Pharmaceutical, food and medical devices companies that market their products and services in Europe face an intricate web of rules and regulations. EU regulation is continually evolving: it is adopted in Brussels, applied by European and national administrations and interpreted by the European and national courts. In order to ensure compliance, companies need up-to-date, practical advice on how the EU rules affect their industry.

Sidley’s EU life sciences lawyers provide integrated legal services that encompass the entire spectrum of corporate, transactional, litigation and government matters. We have substantial experience addressing a wide variety of regulatory and market access issues related to pharmaceuticals, biotechnology, medical devices, cosmetics, food and food supplements.

Learn more about our EU Food, Drug and Medical Device Regulatory practice.

Sidley’s FDA and CMS Engagement Strategies practice, consisting of more than a dozen lawyers and government relations professionals, is one of the most diverse in Washington, D.C. Our team represents a significant array of clients on legislative matters before the U.S. Congress and the States and develops the public policy rationale behind the modification of healthcare, food and drug and public health laws. Our practice includes several partners who have held senior positions in government and played a major role in the drafting and implementation of many major healthcare laws.

Sidley’s FDA and CMS Engagement practice is distinctive because we have multidisciplinary experience. On any particular problem, Sidley may utilize a team of lawyers and professionals consisting of four former Associate White House counsels, the former Acting Chief Counsel of the FDA, the former General Counsel to the Department of Agriculture and the Office of Management and Budget, the former General Counsel to the United States Trade Representative and over a dozen registered lobbyists. We develop creative solutions to problems because our experience is so deep and diverse. Whether the issue requires knowledge of food and drug law, Medicare, Medicaid, tort law, public health, health financing or trade policy, or knowledge of the players or process involved in a particular Congressional action, Sidley possesses full service capabilities.

Public Policy and Legislative Counseling and Advocacy

Our lawyers closely monitor all healthcare legislation on the federal level and regularly weigh in with key policymakers to advocate positions on behalf of clients. Over the years, Sidley has represented pharmaceutical and biotech manufacturers, device companies, hospitals, large trade associations, clinical diagnostic laboratories, physician organizations, managed care plans, DME suppliers, pharmaceutical distributors, ambulatory surgery centers and other issue-specific coalitions on significant matters pending in Congress or in the Executive branch. We believe that the most effective legislative advocacy combines a substantive knowledge of an issue with a thorough understanding of the legislative process and strong relationships with key policymakers. Our lawyers are highly regarded within their substantive field and are called upon frequently by clients to make presentations before HHS, CMS, FDA, key committees, staff, members of Congress, House and Senate leadership and State legislatures.

As clients grapple with increasingly challenging public policy problems, they frequently turn to Sidley. We work closely with both Democratic and Republican Members of Congress in the House and Senate. We represent clients on “regulatory advocacy” matters – where Members of Congress are called upon to weigh in on implementation of an important rulemaking or Agency decision. Additionally, we lead coalition advocacy efforts on Capitol Hill and develop “white papers,” legal briefs and advocacy presentations to facilitate discussions with lawmakers.

Reimbursement, Coding and Coverage Advocacy

We have substantial experience on coverage, coding and reimbursement issues, and we advocate on such issues on behalf of an impressive array of leading healthcare clients, including pharmaceutical, device and diagnostics manufacturers. We also represent medical societies and healthcare providers in their efforts to interpret and navigate effectively through local contractor and CMS policies. We have years of experience – both inside and outside the government – handling high profile coding, coverage and reimbursement issues. In addition, we are experienced in:

• developing alternative pricing and reimbursement mechanisms;
• obtaining rate “exceptions” under various pricing methodologies;
• facilitating pass-through determinations;
• securing new and temporary codes for reimbursement and coverage;
• working with local contractors on the development of Local Coverage Determinations and CMS on the formulation and implementation of National Coverage Analysis policies;
• successfully opposing the application of price referencing (such as a Least Costly Alternative policy) to clients' products;
• correcting data methodology and payment issues; and
• applying our deep understanding of various drug and device rules to secure appropriate reimbursement across various sites of service.

Sidley’s lawyers have significant experience working on contractor issues and the national policies that dictate the scope of the local contractors’ authority. Several of Sidley’s professionals served as staff co-authors of the relevant statutory provisions governing the Medicare Administrative contractors and revised coverage and reimbursement provisions of the Medicare law. We have represented dozens of clients on pricing and governmental reimbursement issues (including Average Wholesale Price, Average Sales Price, Competitive Acquisition Program, Widely Available Market Price, Average Manufacturer Price, Medicare Part D and Medicaid rebate issues) and work closely with them to ensure the appropriate scope of coverage is provided for their products.

Sidley also provides assistance to clients on the regulatory, strategic pricing and business issues associated with Medicare Part D. Our professionals are highly regarded in Part D and Part B matters in the country and have worked extensively with all of the relevant federal agencies with oversight over regulatory matters.

In connection with our coverage, coding and reimbursement practice, we also meet regularly with various personnel in Congress, CMS, MedPAC, the Office of the Inspector General for the Department of Health and Human Services (HHS-OIG) and other relevant agencies and committees.

Recent Engagements

In recent years, we have successfully undertaken a significant number of legislative and “regulatory advocacy” projects. An illustrative list follows:

• Developed, oversaw and implemented legislative and regulatory strategies for a broad coalition of medical device manufacturers, medical societies and patient groups to enact a new preventive benefit in Medicare to detect abdominal aortic aneurysms;
• Led Congressional and Agency advocacy efforts to oppose the application of price controls on an important, branded pharmaceutical product;
• Secured Part D coverage for several drugs previously ruled to be “non-covered” under the Medicare Program;
• Spearheaded Congressional and Agency efforts to exclude “bona fide service fees” from the definition of ASP on behalf of a trade association of specialty distributors;
• Secured favorable legislative language regarding the importance of limiting “hospital acquired infections,” on behalf of a medical device manufacturer; and
• Working with physician societies, patient groups and others, secured coding and coverage for a number of drugs, devices and other items and services.

Healthcare and life sciences companies operate under expansive government oversight—extending well beyond food and drug and healthcare authorities. Sidley’s Global Life Sciences (GLS) platform helps clients navigate this broader policy and political landscape with insight, discretion, and results.

Sidley’s GLS Other Government Strategies team delivers:

• Capitol Hill Insight and Engagement: We help life sciences clients anticipate and shape legislative activity on issues beyond FDA and CMS oversight—including national security-related supply chain measures, antitrust scrutiny of life sciences M&A, FTC regulation of digital health advertising and data use, SEC ESG disclosure rules impacting biotech and pharma, tax policy affecting R&D incentives, and NIH policy shifts on research funding and data sharing. Our bipartisan team engages directly with key Congressional committees policymakers to advocate for outcomes that align with client priorities and protect long-term innovation.
• Congressional Investigations and Oversight: With deep experience preparing witnesses and responding to high-profile investigations, we defend companies and executives targeted by Congressional inquiries. We coordinate across legal, policy, and communications channels to protect reputations and maintain business continuity.
• Legislative Advocacy with Legal Depth: We don’t just lobby—we deliver informed, strategic advocacy. Sidley combines the influence of a top-tier policy shop with the legal depth of a global firm. We ensure clients’ voices are heard by key legislators, build coalitions, and campaign on matters ranging from antitrust enforcement and M&A review to privacy, ESG, and enforcement risk.
• Public Policy and Enforcement Trends: We track legislative, regulatory, and political developments that influence life sciences—from trade and export controls to drug shortages, cybersecurity, telehealth, and biotech investment restrictions. Our clients benefit from early warnings, practical analysis, and clear positioning strategies.
• Political Law and Compliance: We advise on lobbying disclosure, campaign finance, pay-to-play, and ethics rules to ensure life sciences companies, trade associations, and executives are fully compliant when engaging policymakers.
• Government Experience, Strategic Perspective: Our team includes former senior staff from Congress, the White House, FTC, DOJ, and other key agencies. We bring unmatched institutional knowledge and tactical acumen to every engagement.

Learn more about our Government Strategies practice.

We counsel clients on a wide array of complex issues relating to clinical trials. In particular, Sidley lawyers regularly advise clients on both the FDA regulatory and healthcare issues presented by clinical investigations of new drugs and medical devices (including biological products regulated as drugs and medical devices). One of the distinguishing factors of our clinical trials practice is the extent to which our healthcare lawyers and our FDA lawyers coordinate with each other.

We routinely advise on such essential FDA regulatory matters as whether an investigational new drug exemption (IND) or investigational device exemption (IDE) is required and how the FDA’s commercialization rules apply to standard-of-care products used in trials. We are also called upon to evaluate and advise on high-stakes matters presented in the context of FDA inspections of clinical investigations at academic medical centers and special considerations presented by investigations of novel technologies.

In the healthcare context, clinical investigations raise challenging questions related to reimbursement, physician equity, and fair market value payments to investigators. We routinely address concerns associated with early access and continued access programs.

We are also very experienced in compliance requirements and with federal and state statutes governing fraud and abuse in this area. Moreover, as evidenced by the relatively recent proliferation of clinical trial disclosure requirements at the state and federal levels, an increasing number of government entities are becoming involved in establishing regulatory expectations for drug and medical device companies engaged in clinical research. We work to ensure that the myriad regulatory issues presented by the investigational administration of new medical technologies are thoroughly and efficiently addressed.

Contacts
Meena Datta
Torrey Cope

 

Healthcare and life sciences companies operate under intense scrutiny, navigating a maze of global data regulations. From digital therapeutics to decentralized trials, the risks—and the stakes—have never been higher. Sidley’s Global Life Sciences (GLS) platform delivers unparalleled, industry-specific privacy and cybersecurity counsel—powered by one of the world’s leading healthcare and food, drug and medical device (FDMD) regulatory practices.

• Targeted Digital Risk and Compliance Strategy: We know health data. From PHI and clinical trial records to AI-driven platforms and RWE, we guide biopharma, medtech, diagnostics, and digital health companies through HIPAA, HITECH, state privacy laws, GDPR, and other global privacy, data protection and AI laws and regimes with precision.
• Integrated FDMD and Healthcare Insight: Sidley’s privacy team works shoulder-to-shoulder with our top-ranked FDMD and healthcare practices. Whether addressing a clinical trial breach or building a digital health platform, our counsel covers the full regulatory spectrum.
• Breach Response and Crisis Control: We lead clients through high-stakes data breaches and investigations—coordinating with forensics, PR, regulators, and law enforcement across jurisdictions to manage risk and protect brand trust.
• Boardroom-Ready Governance: We advise boards and executives on cyber oversight, disclosures, and fiduciary risk. Our custom tabletop exercises and playbooks are built for the realities of life sciences operations.
• Trusted on Tech and Innovation: From AI to wearables to cloud-based data, we help clients embed security and privacy into every stage of innovation—balancing speed with trust and compliance.
• Recognized Excellence: Ranked by Chambers USA for “litigation strength and compliance expertise,” Sidley’s 70+ lawyer global team is a go-to partner for cybersecurity and privacy in healthcare and life sciences.

Contacts

Colleen Brown
Francesca Blythe

Learn more about our Privacy and Cybersecurity practice.

Healthcare and life sciences companies face intense scrutiny from the SEC and other regulators as they navigate clinical pipelines, investor expectations, and capital markets activity. Sidley’s Global Life Sciences (GLS) platform pairs deep sector experience with top-tier SEC regulatory counsel to help companies stay compliant, transparent, and positioned for long-term success.

Sidley’s GLS SEC Regulatory team offers:

• Sector-Specific SEC Disclosure Counsel: We advise public and late-stage private companies on complex disclosure matters—from clinical trial reporting and regulatory milestones to risk factor design, MD&A, and investor communications. Our team understands how scientific uncertainty, FDA interaction, and pricing dynamics affect disclosure strategy.
• IPO and Capital Markets Expertise: Sidley is a trusted partner to life sciences issuers preparing for IPOs, follow-on offerings, and SPAC transactions. We guide clients through SEC comment processes, roadshow preparation, and prospectus drafting, ensuring alignment between regulatory, scientific, and financial messaging.
• Post-IPO Compliance Support: We counsel boards and management on 10-K/10-Q disclosures, earnings calls, Form 8-K events, Reg FD, insider trading, and shareholder engagement. Our team helps clients avoid SEC pitfalls while preserving flexibility and credibility with the market.
• Integrated Risk Management: Our lawyers work hand-in-hand with Sidley’s FDA, healthcare, white collar, and litigation practices to advise on disclosure-related risks arising from regulatory delays, compliance investigations, pricing issues, whistleblower complaints, or internal audits.
• Former Government and Industry Experience: Our team includes former senior SEC officials, in-house counsel from major public companies, and Chambers-ranked regulatory partners—delivering practical, proactive advice tailored to the realities of life sciences business and regulation.
• Recognized Excellence: Sidley has been repeatedly honored as Law Firm of the Year in Securities Regulation by U.S. News – Best Lawyers. Our securities team is ranked in Chambers USA and regularly leads on cutting-edge disclosure and compliance matters.

Learn more about our SEC Enforcement and Regulatory practice.

Life sciences and healthcare companies face a rapidly evolving commercial landscape marked by heightened antitrust scrutiny from regulators and private plaintiffs around the world. Sidley’s Global Life Sciences (GLS) Antitrust and Competition team collaborates with clients across the industry to proactively assess and mitigate antitrust risk, navigate complex investigations and litigation, and structure business strategies and transactions to withstand global regulatory scrutiny.

Our team combines cutting-edge antitrust experience with deep industry knowledge, enabling us to offer nuanced advice and strong advocacy that reflect the scientific, regulatory, and commercial realities of the marketplace. Several of our lawyers are former Federal Trade Commission, Department of Justice, European Commission, and State Administration for Market Regulation antitrust and competition officials. They provide an insider’s perspective regarding key government policies that impact antitrust matters.

We are consistently recognized by leading legal directories and publications, including Chambers Global, The Legal 500, Global Competition Review (GCR), LMG Life Sciences, and Who’s Who Legal.

Our Antitrust and Competition team brings extensive experience to clients:

• Global Defense Against Government Investigations: Sidley defends life sciences and healthcare companies in high-stakes civil and criminal antitrust investigations and enforcement actions across the U.S., EU, U.K., and Asia. We frequently advise our clients on leniency applications, as well as help them negotiate remedies or commitments to address concerns of enforcement authorities.
• Defense in High-Stakes Litigation: Our established antitrust litigators have an impressive track record representing life sciences and healthcare clients in civil, criminal, and multi-district litigation proceedings in jurisdictions across the U.S. and internationally. In the U.S., our team routinely handles motions, hearings, trials, and appeals in federal and state courts, whether brought by enforcers or private plaintiffs. In Europe, our team has extensive experience defending clients in high-stakes litigation proceedings challenging actions of competition regulators before the General Court and the Court of Justice of the European Union and national courts.
• Merger Control and Strategic Transactions: We provide full-service antitrust counsel for mergers, acquisitions, joint ventures, and licensing transactions in the life sciences and healthcare industries. We handle global merger control filings and advise on substantive antitrust risks, including implications of new filing thresholds, “dynamic” theories of harm, managing extended periods for pre-notification discussions, managing large requests for—and heavy scrutiny of—internal company documents, and negotiating remedy packages.
• Sector-Specific Antitrust Advice: We regularly provide antitrust advice on government contracting, multi-jurisdictional pricing negotiations, discount and rebate schemes, regulatory exclusivity issues, “product hopping,” product advertising, supply chain management (including stock allocation schemes), life cycle management strategies, as well as distribution, licensing, supply, co-marketing, research and development, and other types of commercial agreements. We also assist life science companies and trade associations in implementing regional and global antitrust compliance programs aimed at avoiding involvement in public authority investigations and civil litigation.

Contacts

Anne Robert
Benjamin Nagin
Benjamin Mundel
Patrick Harrison
Vadim Brusser
Steve Horowitz

Learn more about our Antitrust and Competition practice.

Life sciences companies are increasingly focused on building out and communicating their sustainability commitments and goals to their various constituents – patients, customers, investors and regulators. As life sciences companies seek to navigate the evolving environmental, social, and governance (ESG) landscape, they turn to Sidley for guidance. Sidley’s Global Life Sciences (GLS) team works with life sciences and healthcare companies to manage all aspects of this complex area globally, including the regulatory requirements that are inherent in the ever-changing global ESG landscape— from expanded access to medicines, to reducing waste and improving transparency in the supply chain.

Environmental Law “Law Firm of the Year”
U.S. News – Best Lawyers “Best Law Firms” 2023

How We Add Value

Compliance with sustainability requirements and the achievement of ESG goals require a systematic and organized approach, as well as deep knowledge of both the life sciences sector and the ESG/sustainability legal landscape. Sidley’s multidisciplinary GLS team is well-positioned to assist life sciences companies with the interconnected issues stemming from ESG regulations. We provide targeted ESG strategies to help clients anticipate and prepare for regulatory and enforcement issues on a multinational scale and ensure compliance across jurisdictions.

Leveraging our breadth of experience, global perspective, and deep industry knowledge of the ESG landscape, we assist companies in conducting gap analyses, developing programs to respond to and comply with complex ESG requirements and developing or enhancing policies and procedures required to meet such ESG commitments as achieving net-zero targets, limiting the use of natural resources, and reducing waste. Our GLS team regularly advises on the most pressing social issues material to life sciences companies, including options to improve existing manufacturing processes while maintaining high levels of quality assurance and complying with the GxP requirements applicable throughout the product lifecycle. The Sidley GLS team recognizes that with the complexity of managing a worldwide ESG program, a global multidisciplinary and industry-specific approach is necessary; we partner with life sciences companies to meet these demands holistically. Our lawyers also have extensive experience in tackling the corporate governance challenges faced by the life sciences industry, including by developing tailored compliance programs and advising corporate management, boards of directors and board committees on corporate responsibility, fiduciary duties, and board oversight responsibilities. 

1 of only 4 firms ranked Band 1 worldwide for Crisis Management
Chambers Global 2023, Crisis & Risk Management

About Our Team

Our Global Life Sciences practice, including our Healthcare and Food, Drug, and Medical Device regulatory and compliance and enforcement practices, bring to bear a multidisciplinary approach and diverse pool of skillsets, informed by a deep understanding of the life sciences sector from both a business and legal perspective. Our teams across the globe include members with decades of governmental, medical, and in-house experience, giving us insights into the expectations of regulatory authorities as well as the needs and challenges faced by global companies.

Our ESG experience — combined with our extensive network of resources and our longstanding relationships with leading industry associations such as EFPIA, EU MedTech, and PhRMA — enables us to effectively advocate for, and provide guidance to, our clients. We have counseled and represented biotechnology, biopharmaceutical, and medical technology clients on countless ESG/sustainability regulatory and compliance issues, from advising on ESG-related disclosures and negotiating shareholder proposals relating to ESG topics, to ensuring compliance with the most recent ESG regulations and developing tailored policies and procedures.

“Sidley has a broad range of expertise and a deep understanding of environmental regulations.”
Chambers USA 2023, Nationwide Environment

Integrated Service Offering

Sidley’s Global Life Sciences ESG and sustainability platform encompasses in-depth knowledge of managing risks throughout the life sciences product value chain, including practical insight into:

GxP principles Research and development Clinical trials Affordable medicines Patient data Access to Healthcare

Pharmacovigilance Complex supply chain Chemical substances Waste management Ethics, anti-bribery, and anti-corruption Data privacy and cybersecurity

Learn more about our ESG and Sustainability practice.

In an era of geopolitical volatility, supply chain disruption, and rapidly evolving global regulation, life sciences companies must navigate international trade, customs, export controls, and economic sanctions rules with care and confidence. Sidley’s Global Life Sciences (GLS) platform connects sector-specific insight with elite global trade counsel to help companies manage risk, maintain market access, and seize opportunity across borders.

Sidley’s International Trade practice delivers:

• Life Sciences-Focused International Trade Strategy: From active pharmaceutical ingredients and biologics to medical devices and controlled technology, we advise life sciences clients on import/export compliance, market access barriers, and cross-border regulatory regimes. We help clients align global operations with U.S., EU, and multilateral trade policy that impact product movement, pricing, and distribution.
• Customs and Supply Chain Guidance: We support manufacturers, CDMOs, and distributors in navigating tariffs, customs classification, valuation, and origin issues—especially critical as companies navigate reshoring, diversification, and de-risking of global supply chains. Our team helps secure favorable rulings, mitigate duties, and resolve audits and investigations at the border.
• Economic Sanctions and Export Controls: Sidley advises on U.S. and EU economic sanctions, export control regimes (e.g., EAR, ITAR), and blocked party screenings. We support life sciences companies with compliance programs, licensing strategies, enforcement defense, and crisis response when engaging in sanctioned jurisdictions or dealing with dual-use technologies.
• Multilateral Trade and Government Advocacy: Our team represents clients before the U.S. Trade Representative (USTR), EU trade regulating bodies, and the World Trade Organization (WTO), advocating on issues such as discriminatory regulatory frameworks, intellectual property enforcement, and cross-border digital health trade barriers.
• Recognized Excellence: Sidley is the only team ranked Band 1 for International Trade in every major jurisdiction for Chambers & Partners: Global-wide, Europe-wide, Asia-Pacific, and USA (2017-2025). Our International Trade practice is recognized globally for helping clients succeed at the intersection of international law, policy, and business.

Contacts

Justine Fassion
Ted Murphy

Learn more about our Global Arbitration, Trade and Advocacy practice.