Provided by Goodwin
Headquartered in Washington, D.C., Goodwin’s Life Sciences Regulatory & Compliance (LSR&C) practice leverages our FDA, healthcare regulatory and compliance expertise to focus on the specific needs of the pharmaceutical, biologic, medical device, diagnostic, laboratory testing, and digital health industries. We work with all manner of companies, from those serving the rarest disease populations to those developing technologies designed to detect, treat, and prevent the most prevalent health issues around the world. Our clients’ products include therapeutics (biotechs, pre-clinical, clinical, and commercial-stage companies) to diagnostics (advanced laboratory testing and diagnostic test makers) to medical technology (from durable medical equipment to surgical robotics). We provide strategic counseling at every step in the medical product lifecycle, from idea conception through commercialization. We successfully and efficiently handle complex regulatory demands from a wide variety of regulators, including the FDA, the Department of Health & Human Services, Office of Inspector General (OIG), Department of Justice, DEA, FINRA and the SEC. Our team complements Goodwin’s corporate transactional and licensing capabilities through early involvement with life sciences clients and a comprehensive understanding of the ever-changing regulatory environment which clients must navigate.
Provided by Chambers
Counsels a broad range of clients including pharmaceuticals and medical device manufacturers on complex FDA regulatory issues. Noted for its significant expertise in compliance related to new drug and device development and its strong cross-border capabilities. Also acts on transactions such as the sale of drug rights.
Provided by Goodwin
Goodwin acted as FDA regulatory counsel to Fresenius Medical Care North America.
Provided by Chambers
"Goodwin's responsiveness is outstanding."
"The team has extensive healthcare expertise that is particularly helpful with complex matters."
"Goodwin's team are strategic and have deep industry experience."
"Goodwin's responsiveness is outstanding."
"The team has extensive healthcare expertise that is particularly helpful with complex matters."
"Goodwin's team are strategic and have deep industry experience."
Provided by Chambers
Kirk Ogrosky has a stellar reputation in contentious healthcare fraud matters, including whistle-blower disputes, criminal proceedings and investigations.
Julie Tibbets has a dynamic regulatory practice focusing on pharmaceutical and medical products.
"Julie is great, I have tremendous respect for her and she provides excellent client service."
"She is extremely responsive and solutions-oriented."