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医疗器械注册·法规咨询·CRO服务
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Featured Services
Innovative medical device service, agent service, registrant service, expert discussion meeting,GCP/GSP/GMP/GLP verification
Registration Services
Protocal planning, risk classification, CER , inspection and testing, product type testing, registration application and declaration
Clinical Evaluation
Protocal design, site selection, protocal filing application, ethical discussion, supervision and inspection, data management, biostatistics, report writing
CER
Literature search, clinical data, literature translation, data summary,
comparative analysis, report writing
Regulatory Communication
International regulatory exchange, GMP/FDA and CE consulting services, policy and regulatory interpretation
Quality System
System planning, system establishment, operation guidance,verification and coordination, system rectification, continuous improvement
医疗器械注册·法规咨询·CRO服务
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北京9999js金沙老品牌专注于全球医疗器械注册、法规咨询和CRO服务,3000余成功案例
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