- Optimization of necessary nonclinical studies for development and schedule
- Evaluation of nonclinical study data and go/no-go decision on drug development
- Suggestion of additional study designs to resolve issues
- Support of preparation of submission materials to regulatory authorities(IB, CTD, PMDA pre-consultation materials, interview advice meeting materials, and response to queries from regulatory authorities)
- Participation in PMDA pre-consultation and interview advice meetings
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專業認證動物實驗室/醫療器材生物相容性試驗專業服務