- Preparation of the PMDA pre-consultation materials and interview advice meeting materials
- Translation of package inserts into japanese
- Preparation of IB(1 and CTD
- Translation of CTD into Japanese and editing
- QC of IB and CTD
- Preparation of responses to querises from regulatory authorities
- Translation of nonclinical related documents into Japanese
- Various types of consulting
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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