US
FDA: Medical Device
| FDA: Medical Devices — Highly Recommended |
|---|
| Hogan Lovells |
| Hyman Phelps & McNamara |
| King & Spalding |
| FDA: Medical Devices — Recommended |
|---|
| Arnold & Porter |
| McDermott Will & Emery |
| Morgan Lewis & Bockius |
| Ropes & Gray |
| Sidley Austin |
FDA: Pharmaceutical
| FDA: Pharmaceutical — Highly Recommended |
|---|
| Covington & Burling |
| Hogan Lovells |
| Hyman Phelps & McNamara |
| Sidley Austin |
| FDA: Pharmaceutical — Recommended |
|---|
| Arnold & Porter |
| King & Spalding |
| Morgan Lewis & Bockius |
| Ropes & Gray |
| Lawyer | Section | Practice Area | Location |
|---|---|---|---|
| Dormer, Robert A | Regulatory | FDA: Pharmaceutical, FDA: Medical Device | Washington, D.C. |
| Gibbs, Jeffrey N | Regulatory | FDA: Pharmaceutical, FDA: Medical Device | Washington, D.C. |
| Gilbert, John | Regulatory | FDA: Pharmaceutical | Washington, D.C. |
| Karst, Kurt | Regulatory | FDA: Pharmaceutical | Washington, D.C. |
| Kirschenbaum, Alan | Regulatory | FDA: Pharmaceutical, FDA: Medical Device, Healthcare Pricing & Reimbursement | Washington, D.C. |
| Sasinowski, Frank J | Regulatory | FDA: Pharmaceutical | Washington, D.C. |
| Shapiro, Jeffrey | Regulatory | FDA: Medical Device | Washington, D.C. |
| Torrente, Josephine | Regulatory | FDA: Pharmaceutical | Washington, D.C. |
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Regulatory
Hyman Phelps & McNamara
Hyman Phelps & McNamara is a boutique law firm that solely focuses on regulatory matters. The firm assists a variety of pharmaceutical and medical device companies with their regulatory issues. As a boutique, Hyman Phelps provides clients with FDA expertise throughout all stages of product development, including pre-market approvals and compliance, to post-market labeling, advertising and promotion. "[The] attorneys are very knowledgeable on the areas they counsel on," a client says. "They are have good availability for calls and provide timely responses."
Jeffrey Gibbs offers his extensive experience handling FDA regulatory issues on behalf of clients in the life sciences industry. His active practice primarily involves counseling medical device companies. Gibbs assists with regulatory strategy, 510(k) clearances, approvals, and post-market regulation advice and guidance. "Jeff is a highly skilled and knowledgeable lawyer, but also a wonderful person," a peer says.
On the pharmaceutical side, Josephine Torrente assists companies at every stage of product development, from pretrial counseling to post market representation in front of the FDA. For her work in this area, Torrente was awarded Regulatory Attorney of the Year in Pharmaceuticals by LMG Life Sciences. According to a peer, Kurt Karst is a "go-to guy for all questions pertaining to FDA practice. [He is] just a super nice guy and super confident."
Jeffrey Shapiro is highly regarded for his work representing clients in the medical device area. Shapiro has over 20 years of experience assisting clients before the FDA and is considered an expert in the regulation of combination products. "Jeff Shapiro and his team have done a fantastic job for us in many circumstances, including high pressure situations with short deadlines," a medical device client says.