● 美国CAP 认证

● US FDA GLP现场检查

● OECD GLP认证

● NMPA GLP认证

● 国际AAALAC认证

成都华西海圻医药科技有限公司

WestChina-Frontier PharmaTech (WCFP)

支撑中国新药创制 服务全球新药研发

Support China’s New Drug Creation Serve Global New Drug R&D 02

PART 01 公司概况

国外资质认证·····································································································································01

设施规模 动物福利························································································································02

先进的实验室信息系统···············································································································04

质量保证体系·····································································································································05

成熟的试验操作技术体系·········································································································06

PART 02 功能实验室

组织病理学···········································································································································07

细胞及免疫学·····································································································································09

供试品管理···········································································································································11

临床检验·················································································································································13

生物分析·················································································································································15

PART 03 试验研发

完善的非临床研究服务体系···································································································17

安全药理学试验································································································································18

一般毒性试验·····································································································································19

遗传毒性试验·····································································································································20

致癌试验·················································································································································21

免疫原性及免疫毒性试验·········································································································22

生殖和发育毒理试验····················································································································23

依赖性试验···········································································································································24

药代（毒代）动力学试验·········································································································25

药效学试验···········································································································································26

PART 04 海圻特色平台··································································································································27

PART 05 合作伙伴··············································································································································29

目录

CONTENTS

支撑中国新药创制 服务全球新药研发

Support China’s New Drug Creation Serve Global New Drug R&D 02 基于华西海圻已建立的成熟的精神神经类药物\\麻

醉药物评价平台、吸入药物评价平台、眼科药物

评价平台、细胞类药物评价平台以及透皮制剂评

价平台等，能够为客户提供化学药、生物药、疫

苗、中药、细胞产品、基因治疗产品等非临床有

效性、安全性及药代动力的全套研究评价。

迄今完成千余个药物的非临床研究评价，其中近

百个新药成功申报美国FDA、欧盟及澳大利亚等

国，并进入各期临床试验。华西海圻始终秉承高

质量、规范化、科学化、高效率的优质服务，建

立了良好的行业品牌与信誉，竭诚与国内外的医

药企业、研发机构建立长期友好合作关系。

01 公司概况

Company Overview

PART

ONE

公司简介

成都华西海圻医药科技有限公司是一家与国际接

轨、国内一流的药物非临床研究评价专业化机

构，致力于提供高质量的药效学、毒理学、药代

动力学及生物分析等研究评价，支持药物全球注

册申报。拥有强大的科学、技术、法规及管理团

队，一流的实验设备配备了国际先进的检测设备

和分析仪器。

安全性

评价服务

药效学

评价服务

药代动力学

评价服务 国际双语申报

支撑中国新药创制 服务全球新药研发

Support China’s New Drug Creation Serve Global New Drug R&D 03

动物福利 & 设施规模

成都华西海圻遵照国内外实验动物的管理法规与技术标准，在实验动物、动物设施、动物操作、动物

饲养、兽医、动物福利等方面建立了高水平的管理规范与操作流程；设立实验动物管理与使用委员会

（IACUC）监督动物的管理与使用；建立了完整的兽医、人员培训、职业安全体系，确保规范化地使用实

验动物和动物设施，保障动物福利。

设施规模

● 设施规模共8万平方米

高新区设施规模近3万平方米

生物城设施规模近5万平方米

● 具备同时开展100余个新药临床前评价的能力。

机构图（一） 机构图（二）

支撑中国新药创制 服务全球新药研发

Support China’s New Drug Creation Serve Global New Drug R&D 03 先进的实验室信息系统

按照电子数据管理的国际GLP管理要求，建立国际先进的、基于私有云模式的LIMS信息化平台，实现了实

验数据的电子化、数字化、实时采集，所有数据可溯源并符合国际标准，实现了试验数据的有机整合。

建立安全的IT防护系统与数据备份程序，确保电子数据的安全与备份。建立了符合美国FDA要求的SEND

（Standard for Exchange of Nonclinical Data）数据转化系统

试验信息管理系统

Pristima Suite

生物分析信息管理系统

Watson LIMS

生物分析数据采集与处理系统

Unifi

药代动力学分析系统

WinNonlin

遥测生理信号采集与分析系统

Ponemah DSI/AcqKnowledge

实验动物设施环境监测系统

EMS

实验室温湿度监测系统

WSD

冰箱温度管理系统

MTR

客户服务系统

(CSS)

电子数据转换系统

SEND

实验室信息系统

支撑中国新药创制 服务全球新药研发

Support China’s New Drug Creation Serve Global New Drug R&D 04

质量保证体系

秉承客观、严谨、求实的质量理念，遵照NMPA、

OECD或FDA 的GLP规范、试验方案及SOPs要求独

立开展质量监督，确保安全性试验的GLP依从性，

保障试验数据的真实、完整、可追溯性。

建立了系统化、标准化的QA检查规范与记录体

系，QA对试验方案、试验设施、试验过程、人员

资质与能力等各个试验与管理环节进行检查，确

保试验研究的规范性。

质量保证团队：

项目管理团队：

日本、韩国 GLP检查

2023年华西海圻分别高品质通过了日本、

韩国GLP的现场检查

NMPA GLP认证

2004年华西海圻成都新药安评中

心首次通过认证，迄今顺利高品

质通过每次复认证……

2022年华西海圻天府新药研究中

心首次通过认证��

美国CAP 认证

2014年华西海圻成都新药安评中心首次通过认

证，迄今顺利高品质通过每次复认证……

US FDA GLP现场检查

2017年首次通过现场检查、2022

年通过项目线上核查…

OECD GLP（荷兰）认证

2014年华西海圻成都新药安评中心首

次通过认证，多次顺利高品质通过复

认证……

AAALAC国际认可

2007年华西海圻成都新药安评中心首次通过认证，

迄今顺利高品质通过每次复认证……

2020年华西海圻天府新药研究中心首次通过认证，

迄今顺利高品质通过每次复认证……

资质认证

质量管理：

秉承客观、严谨、求 实 的质量理 念 ， 遵 照

NMPA、OECD或FDA 的GLP规范、试验方案及

SOPs要求独立开展质量监督，确保安全性试验的

GLP依从性，保障试验数据的真实性、完整性和

可靠性。

培训管理：

资质认证：

成都华西海圻医药科技有限公司

WestChina-Frontier PharmaTech (WCFP)

地址：xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

电话：86 28 xxxx xxxx 传真：86 28 xxxx xxxx

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