Drug CDSCO Registration

At JR Compliance, we provide expert regulatory support for pharmaceutical drug registration and licensing under CDSCO and the Drugs & Cosmetics Act. Our regulatory affairs specialists guide you through the appropriate approval pathway based on your drug category, whether new drug, generic, or biological product. We prepare comprehensive dossiers including Chemistry, Manufacturing & Controls (CMC) data, stability studies, and clinical trial documentation. Our team manages the entire approval process on the SUGAM portal, coordinates with Subject Expert Committees, and handles queries from CDSCO officials. We assist with import registrations, manufacturing license applications, and clinical trial approvals as per regulatory requirements. Post-approval, we offer pharmacovigilance support, license renewals, and ongoing compliance management for your pharmaceutical portfolio.