Cooley

Healthcare & Life Sciences Regulatory

Leading team counsels on extensive scope of health care regulatory issues and defends companies in regulatory investigations

Deep US and global experience providing regulatory counseling and advice on FDA, fraud & abuse, corporate compliance, contractual relationships, Sunshine Laws, reimbursement, government program price reporting, healthcare data privacy, licensure and accreditation, health reform counseling, regulatory due diligences, MHRA and CE Marking
Advise all players in the evolving ecosystem, including payors, providers, LS companies, health IT and investors
As connectors to the ecosystem, we counsel clients on how to launch innovative products and services
Represent healthcare clients in connection with federal and state government investigations, inquiries, settlements and voluntary disclosures, leveraging subject matter expertise and litigation and negotiation experience
Counsel related to privacy and data protection, government contracts and government analytics practices provided by multidisciplinary team bolstered by industry leading lawyers
Frequent contributors on groundbreaking regulatory topics at leading industry events, editorial boards and relevant media and publications
Market leader in life sciences – #1 in IPOs, M&A transactions, venture financings and licensing

Updates and news related to health regulatory issues.

CBI's PAP Legal Update (September 25, 20017)
Drug Pricing Transparency Congress (September 27, 2018)
Let's Talk Compliance Series: How Do We Ensure The Success of Our Compliance Efforts? (October 3, 2018)
18th Annual Pharma and Med Device Compliance Congress (November 6, 2017)
Regulatory Roundtable Series (next program coming soon)

Team includes lawyers ranked in Chambers USA, Best Lawyers, LMG Life Sciences Stars and Legal 500
Practice head Wendy Goldstein was named by LMG Life Sciences as "Attorney of the Year" for Healthcare Pricing and Reimbursement in 2013

Wendy Goldstein Partner, New York

Mazda Antia Partner, San Diego

Natasha Leskovsek Partner, Washington, DC

Sarah diFrancesca Partner, New York

Phil Mitchell Partner, New York

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