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
Goodwin 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.
Goodwin provided regulatory counseling to Alnylam Pharmaceuticals on product development and marketing matters across its portfolio of products.
Provided by Chambers
The Goodwin team is incredibly responsive, and what distinguishes them is that they are very commercial-minded and practical.
Goodwin provides prompt, thoughtful, and practical advice. We have received the guidance we're looking for in a straightforward, responsive manner.
Goodwin has expertise from regulatory and legal spanning drug and devices, and personnel working with us responded quickly to our inquiries.
The Goodwin team is incredibly responsive, and what distinguishes them is that they are very commercial-minded and practical.
Goodwin provides prompt, thoughtful, and practical advice. We have received the guidance we're looking for in a straightforward, responsive manner.
Goodwin has expertise from regulatory and legal spanning drug and devices, and personnel working with us responded quickly to our inquiries.
Provided by Chambers
Julie is very skilled in FDA matters and in understanding the regulatory landscape. She is skilled at coming up with potential solutions that let businesses move forward.
Whether we're looking for a quick gut-check or thorough analysis, we can rely on Julie. Her guidance is prompt and practical and we appreciate the bench-marking she can provide.
Matthew Wetzel of Goodwin has solid experience in the healthcare regulatory space, regularly handling FDA approvals and regulatory compliance matters for pharmaceutical and medical device companies.
Matthew is a great lawyer with great industry knowledge and guidance.