Led by senior industry specialists, the company’s regulatory filing team has in-depth knowledge of regulatory frameworks and review logics of major authorities including NMPA (China), FDA (US) and EMA (EU). We provide forward-looking regulatory strategy guidance across the full lifecycle of drug development, to ensure tight alignment between filing strategy and product development timelines.
Supports global filing pathways such as IND, BLA and MAA, with strategies synchronized in real time with CMC, non-clinical and clinical development. We enable China-US parallel filings, China-EU synchronized submissions and multi-region global regulatory system setup, unifying the core evidence package while meeting region-specific requirements.