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BakerHostetler LLP
Department profile | BakerHostetler LLP
Healthcare: Pharmaceutical/Medical Products Regulatory

Chambers Review

Provided by Chambers

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

3
Band 3

What the Team is Known For

BakerHostetler LLP has 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 is defending multiple GLP-1 compounders in response to complaints filed by Eli Lilly & Co.

Strengths

Provided by Chambers

The team is innovative, strategic and has knowledge of the law. They have a bench strength of talent for complicated matters.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

The firm stands out for its deep understanding of the pharmaceutical and compounding industry, particularly in navigating complex regulatory and compliance matters.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

I am very impressed with the entire team at BakerHostetler. The entire team is knowledgeable and provides commercial-focused legal advice.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

Healthcare, life sciences and medical device regulatory environment is not always black and white. They do a solid job of navigating these areas and providing advice and guidance.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

Notable Practitioners

Provided by Chambers

Lee H Rosebush
3
Lee H Rosebush
3
Band 3
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 a deep understanding of the industry and acts as a strategic business and legal adviser. Lee also has in-depth connections throughout the pharmaceutical, pharmacy and healthcare industries.

We consider Lee to be a member of our team and trusted adviser. He is excellent to talk to and exercise thoughts.

Lee is respectful and genuinely cares about our results.

Lee is one of the most plugged-in attorneys in the US when it relates to 503B matters.

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Marc N Wagner
Marc N Wagner
Star Associates

Marc Wagner is recognized as a star associate for his ability to handle a broad spectrum of FDA and DEA issues, including regulatory support, investigations and litigation. His clients include pharmaceutical and healthcare organizations.

Marc is extremely knowledgeable and well-versed in matters to our business.

Marc has great experience in the pharmaceutical and pharmacy industries. His work product is excellent and turns around deliverables in a quick timeframe.

Marc understands all aspects of the industry and consistently executes with excellence.

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Ranked Lawyers at
BakerHostetler LLP

Provided by Chambers
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District of Columbia

Healthcare: Pharmaceutical/Medical Products Regulatory
Lee H Rosebush
3
Lee H Rosebush
3
Band 3
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Marc N Wagner
Marc N Wagner
Star Associates
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