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近日，我司成功协助北京联众泰克科技有限公司的抗原自测试剂盒获得欧盟自测CE认证资质。在此之前，我司已成功协助诸多国内外企业获得该资质。IVDEAR凭借高效、专业的技术服务，得到大量IVD企业的信任和支持。
IVDEAR为联众泰克提供了以下帮助：从案件的申请受理到技术文件的准备、预审核，临床实验研究解决方案、可用性研究解决方案、审核整改协助、获得证书，提供了全过程、全方位的技术咨询服务。为联众泰克提供了高效、快捷、专业的技术咨询服务和渠道资源支持，帮助企业在第一时间获得了CE自测证书。
IVDEAR在新冠试剂盒国际注册及临床研究解决方案积累了大量的经验和资源，目前IVDAER已与国外多家临床实验机构建立了良好的合作关系。IVDAER建议有条件的企业，在获得自测CE后，可考虑申请英国CTDA注册、香港注册，有利于企业进一步提高市场竞争力，开拓国际市场业务。
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