About the Company

北京弘颐润和管理咨询有限公司专注于医疗健康领域,提供精准的医疗器械法务咨询和专业的产品上市技术服务。为上百家企业提供了咨询服务,产品涵盖高风险植介入医疗器械、口腔科器械、有源手术器械、医用软件、医用诊察和监护器械、急救器械、物理治疗器械、眼科器械、辅助生殖器械、医用康复器械、临床检验器械、诊断试剂等。公司目前为国内多家器械知名企业提供长期顾问服务。
公司核心团队在药监系统有十几年的监管、审评经验,参与多项医疗器械注册、生产监管、质量管理体系、临床试验法规规章起草,技术力量雄厚,经验丰富,与监管机构,检验机构,临床机构、科研院所、医疗器械行业协会等建立了良好的关系。
公司可以为客户规划合理的医疗器械转化路径,并在法律法规、国行标、指导原则等方面给予合理、专业的指导与建议,帮助客户规避产品转化、注册过程中的各种风险及损失,将注册环节中的发补降至*低,协助企业产品尽快通过注册审批,早日完成产品转化。

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Operating Status: 开业
Registered Capital: 200万(元)
Legal Representative: 杨雷
Date Established:
Credit Code: 91110108MA00BF5N8P
Registered Address: 北京市顺义区金航西路4号院2号楼4层419室-Y010(天竺综合保税区)

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