We customarily provide drug development regulatory services (including for clinical trials, PK/PD/BA/BE studies, and for preparing regulatory dossiers) to various major pharmaceutical companies & sponsors in India, US and Japan. Services offered include: 1. Providing guidance on Indian regulatory environment & requirements, 2. Compiling dossiers, 3. Making regulatory submissions, 4. Liaison on behalf of clients, 5. Query resolutions at the office of Drugs Controller General (India), and 6. Receiving registration documents on behalf of clients Our clear understanding of Indian regulatory requirements and excellent liaison with regulatory authorities facilitates swift approvals in India. Our interface substantially speeds up the process of regulatory clearance for your protocols and dossiers.