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
2006-2025 上海博華國際展覽有限公司版權(quán)所有（保留一切權(quán)利）
滬ICP備05034851號(hào)-57
