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Technical service
TECHNICAL SERVICE
Regulatory registration and approval Third party audit and training Inspection service Research and custom services
Regulatory registration and approval
总览
Under the leadership of experts with many years of registration management experience, the technical Center is composed of several senior registrants with rich registration experience。 Zhejiang Chemical RA is familiar with national and international registration regulations and guidelines, can develop a viable registration strategy for you, and liaises closely with various regulatory authorities on technical and regulatory issues。
Regulatory registration and approval
Drug registration in China
• Served as liaison officer for the State Drug Administration
• Feasibility assessment of domestic registration
• Review and provide guidance to further improve registration documentation
• Prepare (including translation) and submit registration documents
• Review quality standards
• Tracking during registration


Foreign drug registration
Acting as liaison to health authorities in Europe, the United States, Chile, Costa Rica, Panama
• Feasibility assessment of domestic registration
• Feasibility assessment and registration plan for drug registration
• Compile the API's DMF file
• Compile the CTD file of the product