“The multitude of perspectives and experiences Sidley Austin can bring to complex regulatory matters are extremely helpful in high-stakes situations.”
Chambers USA 2023, Healthcare - Pharmaceutical/Medical Products Regulatory
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.
“The Sidley lawyers are absolutely spectacular. They are commercially savvy, provide indispensable support, and have fantastic experience.”
Chambers USA 2023, Life Sciences - Regulatory/Compliance
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:
- 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
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- 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)
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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.
