FDA Counsels 23602 Sidney Bay, Dana Point, CA 92629

FDA Counsels is a full-service legal, regulatory, and compliance consulting firm located in Southern California. Led by Steven A. Johnson, who has extensive experience in representing pharmaceutical and device companies in navigating FDA legal and regulatory requirements. With a background as an Associate Chief Counsel for Enforcement at the FDA, Mr. Johnson has successfully defended companies in litigation before the US District Court and has a proven track record of handling FDA-related issues.

The firm provides a range of services including spearheading strategies to fight FDA proposed withdrawals, developing strategies for filing and approval of New Drug Applications (NDA), serving as FDA counsel to major compounding pharmacies, and coordinating recalls of pharmaceutical products. Mr. Johnson also offers FDA legal services for the life cycle of life sciences companies, helping clients with transactions, enforcement, and crisis management.

FDA Counsels also hosts special closed-door sessions, such as the Chief Compliance Officer Round Table, to provide industry professionals with valuable insights and updates on FDA compliance issues. With a commitment to providing high-quality educational programs, FDA Counsels ensures that its clients are well-informed and prepared to navigate the complex landscape of FDA regulations.

Located at 23602 Sidney Bay, Dana Point, California, FDA Counsels is a trusted partner for companies seeking expert guidance on FDA legal and regulatory matters. Whether you are facing FDA-related challenges or need assistance with compliance issues, FDA Counsels is dedicated to helping you successfully navigate the maze of FDA requirements.