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Driven to help you achieve your business goals wherever they may take you in the world, Sidley’s pioneering Global Life Sciences practice comprises an experienced team of approximately 200 lawyers across numerous legal disciplines in our offices around the world. We understand the challenges you face in the course of conducting business across the global drug and device supply chain, having counseled high-profile clients in every sector of the dynamic life sciences industry.

Advising on the full scope of regulatory, compliance and enforcement, litigation and transactional matters, we can offer you a holistic legal approach that will smooth your path as you navigate industry changes, technological advances, market demands and policy hurdles.

“I find them to be exceptionally well versed on a large number of issues. There never seemed to be an issue that they couldn't help address. They’re exceptionally good on any number of issues.”
Chambers Global 2021, USA: Life Sciences & Pharmaceutical Sector (International & Cross-Border)

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“The team is very practical and has a deep industry experience.”
Chambers USA 2021, Nationwide, Life Sciences

Attuned to Your Needs 

Uncommon insight to your work. Many members of our team hold advanced technical degrees, making us uniquely adept at handling complex scientific and clinical issues. Our insider’s perspective of government is also an important feature we bring to bear in advising your multi-faceted, multinational business across borders, cultures and tough legal terrain. A number of our lawyers have years of experience serving in senior roles at key regulatory agencies. Our team’s substantial government credentials include successfully representing clients before agencies such as the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services, the U.S. Department of Justice, the European Commission and the National Medical Products Administration, formerly known as the China Food and Drug Administration.

A seamless global structure is the bedrock of our practice. Spanning three continents, our integrated team works together as a cohesive unit to provide pioneering legal advice on the biotechnology, pharmaceutical and medical device industries. Our deep bench and global reach allow us to be nimble, staffing up any size matter at a moment’s notice anywhere in the world.

We understand the unique challenges of global innovators. While charting new terrain with pioneering gene and cell therapies, high-tech software and borderline products, our clients simultaneously confront complex regulations that struggle to keep pace with the evolving technologies. With decades of experience and in-depth knowledge of the regulatory environment, we have advised on significant, often novel issues, at every stage of the product life cycle.

Responsiveness and practical problem-solving are at the heart of our work. We know and seek to remedy the pressures you face in the course of accomplishing your business objectives. The team is also proactive in response to issues breaking on the ground. By prioritizing and preemptively addressing contentious issues, we can help you stay ahead of the curve. This includes engaging with the regulators early and often, and in a way that maintains our positive relationships with them.

“They are very experienced in the life sciences industry; they deeply understand the dynamic, the challenges and the concerns of the industry.”
Chambers Global 2021, USA: Life Sciences & Pharmaceutical Sector (International & Cross-Border)

Industry acumen defines our team. Our deep bench comprises lawyers who have given input into the drafting of the laws and policies that continue to shape the life sciences landscape. This includes more than 100 former senior officials from regulatory agencies and government bodies around the world, such as:

Global Life Sciences
  • the U.S. Department of Health and Human Services (HHS)
  • Centers for Medicare & Medicaid Services (CMS)
  • the U.S. Food and Drug Administration (FDA)
  • the White House
  • the U.S. Department of Justice (DOJ)
  • key U.S. Congressional Committees
 
  • the European Commission 
  • Swissmedic
  • the State Council of the People’s Republic of China (P.R.C.)
  • the Ministry of Foreign Affairs of the P.R.C.
  • the Ministry of Commerce of the P.R.C. (MOFCOM)


A Record of Success

Strong leadership in advising clients has consistently earned us acknowledgement from numerous industry publications, including Chambers Global, Chambers USA and Chambers Asia-Pacific, China Business Law Journal, China Law & Practice, LMG Life Sciences and the U.S. News – Best Lawyers® “Best Law Firms” Survey.

Sidley boasts one of the most experienced and well-regarded life sciences practices in China. As part of the firm’s Global Life Sciences group, our team in China counsels multinational and domestic pharmaceutical, biotechnology, medical device, food/dietary supplements, and agriculture companies on the broad range of issues that arise throughout their business operations.

Healthcare, Pharma & Life Sciences Firm of the Year
China Business Law Journal 2014 & 2018–2022

We were the first international law firm to establish a stand-alone, comprehensive food and drug regulatory practice in China. Since 2007, we have witnessed the drastic changes in China’s regulatory system and how those changes have impacted the life sciences industry on a regional level. During this time, our lawyers have helped clients navigate the ever-changing regulatory environment of the life sciences market.

Sidley was honored with a memorandum of understanding issued by the China Center for Pharmaceutical International Exchange, an institution affiliated with the National Medical Products Administration, previously the China Food and Drug Administration, and by the Shanghai Institute for Food and Drug Safety, under which we provide input into new drug, device, food, and cosmetics laws and regulations.

We bring value to our life sciences clients in the following ways:

  • Industry Knowledge: Our skills and experience cover all areas of the life sciences industry
  • Acute Market Awareness: We are at the forefront of new industry developments, with a focus on structuring and negotiating market-leading terms
  • Proven Track Record: We are the only firm to receive a Band 1 ranking in life sciences for 13 consecutive years by Chambers Asia Pacific/Greater China Region (2010–2022)
  • Commitment to China: Our team brings international industry insight to each project in China, developing benchmarks and best practices to drive innovation
  • Enduring Client Relationships: We believe that our global resources and commitment to providing quality service have led to long-standing relationships with our clients
  • Dedicated Team: We provide direct access to dedicated client teams, ensuring our clients are given the best customized service
“They have extremely rich experience in advising the life sciences industry and also the most cutting-edge knowledge on the development of China’s life sciences industry.”
Chambers Greater China Region 2022

Full-Service Life Sciences Capabilities in China

Our lawyers are active across all areas of the life sciences industry in China, including:

Regulatory

Transactional

Compliance and Enforcement

Dispute Resolution

  • Drugs
  • Digital health
  • Vaccines/biologicals
  • Medical devices
  • Novel therapies
  • Food/cosmetics
  • Animal health
  • Crop sciences
  • Product approval strategies
  • Clinical studies
  • Commercialization
  • Safety vigilance
  • Capital markets
  • Private equity
  • Venture capital
  • M&A
  • Joint ventures
  • Collaboration
  • Licensing
  • Business divestment

 

  • Anti-counterfeiting
  • Anti-bribery/Foreign Corrupt Practices Act
  • Antitrust
  • GxP (good manufacturing practices (GMP), good clinical practices (GCP), and good laboratory practices (GLP)) and quality system regulations
  • Data protection and privacy
  • International arbitration
  • International trade

China Life Sciences Roundtable

We have been hosting our semi-annual event — Sidley’s China Life Sciences Roundtable — for 13 years. The series, held in Beijing and Shanghai, provides an intimate setting for lawyers and compliance officers to engage in an interactive dialogue on timely topics. If you would like to know more about the event, please email sidleychinalifesciencesroundtable@sidley.com.

“They understand very well the historical evolution of various critical regulatory topics and their complex context, which means their legal advice goes beyond the interpretation of laws and is rather a comprehensive guidance to our business.”
Chambers Greater China Region 2022

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