We provide the following services:
1. China Registration Regulatory Advisory
• Regulatory affairs advisory on market authorization
at CDE-NMPA
• Feasibility assessment on market authorization
• Registration pathway suggestion & risk assessment
• Assist in communication with CDE, NMPA
2. China Registration Service
• Pre-IND/Pre-NDA/Pre-BLA meeting application
• IND/CTA/BE application
• Innovative/generic chemical drug registration
(NDA/ANDA)
• Innovative biological products/biosimilars
registration (BLA)
• CMC R&D support before IND
• MRCT (multi-regional clinical trial) application
• Post-approval variation application /re-registration
• Format conversion, validation, and submission of eCTD
• Annual report
