Tag: Outsourcing Facility Registration

Introduction: Why FDA Direct Portal Expertise Is Non-Negotiable In today’s highly regulated U.S. market, US FDA compliance is not optional—it is foundational. Drug manufacturers, private label distributors, outsourcing facilities, cosmetic brands, and logistics stakeholders must comply with strict federal registration, listing, and reporting obligations to legally operate in the United States. The FDA Direct Portals, particularly CDER Direct and Cosmetics…