The District of Columbia is home to a plethora of law professionals, specializing in an array of legal sectors. One in particular that stands out is the area of Healthcare: Pharmaceutical/Medical Products Regulatory law, where legal experts provide invaluable services such as FDA regulatory and compliance advice, new product development strategies, and counsel on a plethora of other healthcare-related issues. In this article, we take a closer look at the profiles of some of the finest Healthcare: Pharmaceutical/Medical Products Regulatory lawyers operating in DC, their respective law firms, and why they are esteemed in this specialized legal field.
Each of these attorneys are lauded for their expertise and demonstrated skills, and bring unique strengths to the table when advising on the highly regulated and frequently changing landscape of the Pharma/Medical Products industry. They assist their clients – ranging from pharmaceutical manufacturers to biotech companies – understand and navigate the complex maze of rules and regulations set forth by governing bodies, notably the Food and Drug Administration (FDA).
Teeming with a wealth of knowledge and comprehension of the intricate healthcare legal sphere, they advocate on behalf of clients in areas of regulatory enforcement, product liability, intellectual property, transactions, compliance matters, and litigation. Herein, we highlight these leading lawyers across top DC law firms, each making strides in the Pharmaceutical/Medical Products Regulatory domain and shaping the global healthcare legal landscape.
Brian Waldman – ArentFox Schiff LLP
Acclaimed for his work in new product strategies and post-market compliance, Brian Waldman is recognized as a powerhouse in the healthcare regulatory space. His expertise also extends into pet food-related regulatory issues. According to one individual, “Brian is outstanding.” Another praised him as a “great attorney who is very knowledgeable in this space.”
Elizabeth Richards – Latham & Watkins LLP
Elizabeth Richards significantly guides pharmaceutical and manufacturing clients on FDA regulatory matters, including establishing clinical settings and new product development. Merged with her prowess in transactional law, Richards is highly lauded. “She’s awesome – she’s very smart, very capable and a pleasure to work with.” Another client stated, “She’s a fantastic lawyer.”
William B Schultz – Zuckerman Spaeder LLP
William Schultz expertly represents stakeholders in healthcare, ranging from pharmaceutical companies to nonprofit organizations. He provides proficient counsel on various FDA regulatory matters. As one client notes, “He’s an extremely respected partner who is an excellent lawyer and counsel for us.”
Jennifer Bragg – Skadden, Arps, Slate, Meagher & Flom LLP & Affiliates
Jennifer Bragg manages a prominent regulatory practice that covers FDA investigations, compliance concerns and white-collar criminal directives. “She’s a really solid, practical FDA white-collar compliance lawyer.” One client expressed, “She’s my absolute go-to person in nuanced matters of FDA law.”
Gregory Levine – Ropes & Gray LLP
Continuing to counsel pharmaceutical and medical product manufacturers on diverse state and federal regulatory matters is Gregory Levine. He’s been described as an “exceptional FDA attorney” who is an “extremely valued partner.”
Philip Katz – Hogan Lovells US LLP
Philip Katz accomplishes an array of FDA matters, effortlessly handling issues relating to orphan drugs designation and regulatory exclusivity. “Philip is great. He’s a smart lawyer who has a wide breadth of experience,” a client mentioned.
David Horowitz – Hogan Lovells US LLP
Known as a veteran who draws on his considerable experience during his tenure at HHS and FDA is David Horowitz. “He has a really good reputation and he’s very knowledgeable,” noted a client.
John Manthei – Latham & Watkins LLP
John Manthei advises pharma, biotechnology and medical device companies on all FDA and other regulatory procedures governing the life sciences sector.
Jeffrey L Handwerker – Arnold & Porter
Operating a thriving regulatory practice and frequently handling federal qui tam litigation, as well as wider pricing and reimbursement mandates is Jeffrey Handwerker. Clients noted, “Jeff is one of the best pricing, healthcare fraud and abuse attorneys around.”
J Benneville Haas – Latham & Watkins LLP
Benneville Haas exhibits excellent flair in advising on FDA regulatory issues, particularly those related to new product development.
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