优势!!!
直接与法规单位沟通联络
缺失回覆与补件均不另行收费
拥有ESG帐号可随时更新资料
GMP品质系统辅导
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注册文件准备与提交辅导
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辅导的范围包含从新药研究开发阶段到药证申请阶段
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辅导的内容包括
- 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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严谨且详尽的文件审查作业
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电子文件提交系统
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