Healthcare: Pharmaceutical/Medical Products Regulatory

About

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.