LIFE CYCLE FIRMS
FIRM PROFILE
ABOUT THE FIRM Sidley Austin LLP is a premier law firm, with a practice highly attuned to the ever-changing international landscape. The firm has built a reputation for being a powerful adviser for global business, with approximately 1700 lawyers in 19 offices worldwide. Sidley maintains a commitment to providing quality legal services and to offering advice in transactional, regulatory and litigation matters spanning virtually every area of law. The firm’s lawyers have wide-reaching legal backgrounds and are dedicated to teamwork, collaboration and superior client service. The firm has offices in Beijing, Boston, Brussels, Chicago, Dallas, Frankfurt, Geneva, Hong Kong, Houston, London, Los Angeles, New York, Palo Alto, San Francisco, Shanghai, Singapore, Sydney, Tokyo, and Washington DC. Global Life Sciences Practice Our team is multi-disciplinary and globally integrated, with lawyers around the world providing advice spanning jurisdictions and bridging the litigation/regulatory divide. We have comprehensive experience in both government and industry, with lawyers who are physicians, those with advanced technical degrees, and still others who are former agency officials. Such knowledge and perspective has enabled us to successfully assist clients across myriad types of business. Below are our areas of practice, featuring information about our global solutions: Food, Drug and Medical Device Regulatory: Sidley assists clients with regulatory issues at all stages of the product life cycle, including good clinical practice (GCP); marketing authorizations; the importation and manufacture of medicinal products and ingredients; good manufacturing practice (GMP); good pharmacovigilance practice (GVP); medical device and food safety; marketing and advertising of medicinal products; labeling; environmental issues; counterfeit products and compassionate use. Enforcement, Litigation and Compliance: Sidley defends manufacturers in criminal, civil and administrative enforcement actions involving pricing and price reporting, anti-kickback issues, off-label promotion, GMP violations, and other violations of the Federal Food, Drug, and Cosmetic Act. We also assist manufacturers to design and implement compliance programs and handle sensitive internal investigations. Healthcare Regulatory: Sidley advises clients throughout the major sectors of the life sciences industry, offering strategic counseling on the critical issues associated with pricing, coverage, comparative effectiveness, reimbursement, fraud and abuse, healthcare information, privacy and antitrust. Government Strategies: Sidley works at the crossroads of law and policy, helping clients develop and implement strategies, that protect and further their business interests. We closely monitor healthcare legislation and regulatory matters on the federal level in the US, EU and Asia, and weigh in with key policymakers to advocate positions on behalf of clients. Products Liability: Sidley has been involved in every type of mass products liability litigation and has an extensive network of experts and local counsel, as well as a reserve scientific literature and legal research. We have handled, tried, and/or appealed cases in nearly every state in the country, as well as in every federal circuit.
Corporate and Technology Transactions: Sidley’s team focuses on corporate, technology and intellectual property transactions from the beginning to the end of the product life cycle, advising companies, funds and research institutions of all sizes, throughout the US, Europe, Asia and Australia. Private Equity: Sidley advises clients on a broad range of domestic and cross-border private equity transactions, including leveraged buyouts, going-private transactions, growth capital investments, venture capital investments and a variety of other acquisitions and financings. Antitrust/Competition: Sidley’s lawyers have particular experience representing pharmaceutical clients in high-stakes litigation and advising on the antitrust aspects of complex commercial agreements such as licensing, research and development and marketing agreements. FCPA/Anti-Corruption: Sidley creates and implements compliance programs, counsels on compliance issues that arise from international sales and marketing activities, assists with FCPA/anti-corruption due diligence on potential acquisitions and other transactions, conducts internal investigations and defends clients in Securities and Exchange Commission and Department of Justice pr ??????????A???????M?????????%?????????1????M???????????????????????????????????????????????????????%??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????M???????????
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