The Best Regulatory insights in Dana Point, California

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.