2 cell quality reports from NIFDC (the most authoritative cell quality report, passed the preliminary inspection in just 2 months (No: SH202400986 & SH202401009)
中科睿极微载体、培养基及重组温和消化酶共获得14项美国DMF备案及2项CE备案(截至2024年6月),产品生产与品控与国际标准接轨,满足客户各阶段需求,助力药物合规申报。
Registered as a pharmaceutical excipient
China No.: F20220000380, US FDA MF #: 29520
NMPA Class I device No. : Yue Chan 20230036, 20240151 & 20240142; Completed the production registration of Class I medical devices for in vitro diagnostic reagents, ensuring that the products comply with regulatory requirements.
ISO 13485:2016 medical devices quality management system
ISO 9001:2015 quality management system
ISO 14001:2015 environmental management system
ISO 45001:2018 occupational health and safety management system
By adhering to standardized and regulated management processes, we enhance the quality level of our products and services to meet customer needs and expectations.
Applied 118 PCs and 83 granted patents (as of May 2025)
Organize & participate in 8 group standards
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