Healthcare: Pharmaceutical/Medical Products Regulatory
USA Guide 2024 : District of Columbia
Band 4
Contact number
+1 202 861 1500Chambers Review
Notable experience in high-profile FDA mandates. Regularly advises pharmaceutical clients and providers as well as private equity funds on regulatory issues such as those connected to new drug applications and advertising matters. Expertise in negotiating pharmacy benefit management contracts. Also offers strong skills in a broad range of transactions including sale of assets and joint ventures.
Work Highlights
- BakerHostetler represented Wedgewood Village Pharmacy in setting up two 503B outsourcing facilities.
Strengths
Provided by Chambers
"BakerHostetler provide timely and multifaceted support to any issue."
"The group is extremely knowledgeable and supportive."
"They are our go-to for complex and sophisticated matters."
"BakerHostetler provide timely and multifaceted support to any issue."
"The group is extremely knowledgeable and supportive."
"They are our go-to for complex and sophisticated matters."
Notable Practitioners
Lee Rosebush has noted expertise in FDA-related compliance issues such as new drug applications and licensing matters. He regularly provides advice to clients in the 503B outsourcing space and has broad knowledge of transactional issues.
"Lee has been a very valuable resource for our company as he has very strong knowledge."
"Lee is strategic and practical in his advice."
Marc Wagner is recognized for his ability to handle a broad spectrum of FDA and DEA issues. His clients include pharmaceutical and healthcare organizations.
"Marc has great experience in the space and his work product is excellent."