Life Sciences and Healthcare Regulatory

Deep US, EU and global experience providing regulatory counseling and advice on FDA, EU and UK regulatory, fraud & abuse, corporate compliance, contractual relationships, physician payment transparency laws, reimbursement, healthcare data privacy, licensure and accreditation, professional licensing and corporate practice counseling, regulatory due diligences, MHRA and CE Marking of medical devices in the EU and UK

Advise clients related to privacy and data protection and provide compliance counseling, transaction structuring, clinical trials and sensitive personal data, contract negotiation and assisting with breach investigations and reporting

Advise all players in the evolving ecosystem, including life sciences companies, HCPs, providers, payors, health IT and investors

Counsel clients on the entire life cycle of their drug and medical device products from classification, through clinical trials and regulatory approval to launch of their innovative products and services

Subject matter leaders in the life sciences and healthcare industry, including former high-level representatives from FDA and DOJ, who are recognized in the industry via numerous accolades, including Chambers and LMG Life Sciences

Represent healthcare and life sciences clients in connection with US federal and state government investigations and national investigations in the EU and UK, inquiries, settlements and corporate integrity agreements, leveraging subject matter litigation and negotiation experience

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