广东国纳康赛医药科技有限公司(简称“广纳康赛”)由广东粤港澳大湾区国家纳米科技创新研究院(简称“广纳院”)和国家纳米智造产业创新中心(简称“国纳智造”)共建而成,执行我国药物GLP、OECD GLP、FDA GLP、日本GLP、CNAS、CMA和国际AAALAC等行业标准或规范,为医疗产品研发与制造机构服务。
Guangdong Canosafe Pharmatech Co., Ltd. (abbreviated as "Canosafe") was jointly established by the The GBA National Institute for Nanotechnology Innovation ("CanNano") and the National Nano-Intelligent Manufacturing Industry Innovation Center("Nano-Intelligent"). The company operates in compliance with industry standards and regulations including Chinese GLP, OECD GLP, FDA GLP, Japan GLP, CNAS, CMA, and international AAALAC requirements, providing services to medical product development and manufacturing organizations.
公司以研究与评价先进纳米医疗产品的非临床有效性和安全性为特色,兼具对其它类医疗产品(包括药品、医疗器械、化妆品、保健品和食品等)的评价,同时协助研发机构的临床试验与产品上市申报。
Specializing in non-clinical efficacy and safety research and evaluation of advanced nanomedical products, the company also conducts assessments of other medical products (including pharmaceuticals, medical devices, cosmetics, health products, and food). Additionally, it supports research institutions in clinical trial applications and market authorization submissions.
公司位于广州市黄埔区,总面积3.07万平方米,配备全动物种属设施,包括SPF级大小鼠、豚鼠、地鼠、免;普通级猴、猪、犬、免、豚鼠、猫、羊;设置ABSL-2、BSL-2、细胞室、组织病理室、临床检验室、分子生物学实验室、生物样品分析室及各类专业手术室;配备了大、小动物用CT、数字减影血管造影X光机(DSA)高精度质谱及各种药物/器械评价所需的先进仪器与设备共约1.5亿元,可充分满足药物/器械相关研究与评价的需要。
Located in Guangzhou's Huangpu District, the facility covers a total area of 30,700 square meters and is equipped with full-spectrum animal housing capabilities, including SPF-grade mice, rats, guinea pigs, and hamsters; conventional-grade monkeys, pigs, dogs, rabbits, guinea pigs, cats, and sheep. The infrastructure includes ABSL-2/BSL-2 laboratories, cell culture rooms, histopathology laboratories, clinical inspection labs, molecular biology labs, bioanalytical laboratories, and specialized surgical suites. The center is equipped with approximately RMB 150 million worth of advanced instruments such as CT scanners for large and small animals, digital subtraction angiography (DSA) systems, high-precision mass spectrometers, and other drug/device evaluation equipment, fully supporting comprehensive pharmaceutical and medical device research and assessment requirements.
公司力求组成一支拥有行业顶级专家及研究人员的一流研究与评价团队,全面开展先进医疗产品非临床有效性、安全性、代谢动力学,乃至机制探索等方面的研究与评价。
The company is committed to building a top-tier research and evaluation team comprising industry-leading experts and researchers, dedicated to conducting comprehensive non-clinical studies in efficacy, safety, pharmacokinetics, and mechanistic investigations of advanced medical products.