優勢!!!
直接與法規單位溝通聯絡
缺失回覆與補件均不另行收費
擁有ESG帳號可隨時更新資料
GMP品質系統輔導
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註冊文件準備與提交輔導
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輔導的範圍包含從新藥研究開發階段到藥證申請階段
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輔導的內容包括
- Investigational New Drug Applications (Drugs) – INDA
- Abbreviated New Drug Applications (Drugs) – ANDA
- New Drug Applications (Drugs) – NDA
- Product License Applications (Biologics) – PLA
- Bulk Pharmaceutical Manufacturers (APIs) – DMF (Taiwan) / eDMF (USFDA/EU)
- Bio Equivalence Testing Facilities
- Packaging materials – eDMF (TYPE III)
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嚴謹且詳盡的文件審查作業
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電子文件提交系統
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