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Service

Registered Consulting

Service scope

◊ Pre-clinical r&d strategy consultation
◊ Clinical r&d strategy consultation
◊ Evaluating the compliance of existing test data
◊ Developing a strategy for registration and declaration
◊ Issuing regulatory gap analysis report
◊ Pre-ind conference organization
◊ Making an appointment for the expert technical communication
◊ Composing clinical and non-clinical data
◊ Writing registration information of drug import
◊ Drug import registration declaration tracking
◊ Assisting and guiding the on-site inspection

Advantage

◊ Technical teams covering the fields of early screening, chemistry and biosynthesis, pharmacodynamics and pharmacokinetics, toxicology and clinical research what can provide comprehensive technical support.
◊ 来自中国科学院、原军事医学科学院以及国家药品监督管理局等机构的评审专家可提供政策及技术支持。
◊ 申报数百个药物的非临床和临床研究资料，积累的丰富的经验和技术资源，同时也和CDE专家建立全方位的沟通联系。
◊ 和CDE建立良好的互动，多次受邀参与CDE发布的技术指导原则类文件的征求意见工作。

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