Provided by Goodwin Procter LLP
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 advised SpringWorks Therapeutics in its definitive agreement to be acquired by Merck KGaA for $3.9 billion.
Provided by Chambers
Goodwin counsel knows our business incredibly well which makes it so easy to reach out for quick questions or input. We would be lost without their efforts.
They blend the business and legal into one really well so they provide actionable advice.
We have only had good experiences working with Goodwin. They have been very responsive at all times.
They provide practical solutions to complex problems. They are trustworthy and continue to work in the best interest of our company. They always make themselves available when needed.
Goodwin counsel knows our business incredibly well which makes it so easy to reach out for quick questions or input. We would be lost without their efforts.
They blend the business and legal into one really well so they provide actionable advice.
We have only had good experiences working with Goodwin. They have been very responsive at all times.
They provide practical solutions to complex problems. They are trustworthy and continue to work in the best interest of our company. They always make themselves available when needed.
Provided by Chambers
Julie is a regulatory FDA expert. Her guidance was invaluable. She was very good.
Julie always provides amazing work.
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.
Matt has hands-on experience as a compliance officer in the life sciences sector. He goes beyond legal advice with government compliance guidance and helps give detailed, practical guidance.
Matt is extremely responsive and client service-focused.
Matthew is absolutely outstanding, he has an excellent rapport within the legal industry.