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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Pharmaceutical DMF/(A)NDA Preparation and Submission
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Back office support in regulatory affairs for regulated markets including product development dossiers and Drug Licensing to pharmaceutical companie
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Expertise in dossier compilation and submission for Pharmaceutical industries such as
- 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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Meticulous review of the dossier ready-for-submission and support.
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eCTD Submission through in e-communications and e-submissions - Electronic Submission Gateway (ESG).
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