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北京宏汇莱科技有限公司

北京宏汇莱科技有限公司〔Beijing HongwayTechnology Co.,Ltd.〕,是一家在北京清华工业开发研究院支持下,由中青年医药专业技术人员及医药法规专家为骨干,在相关部门和科研机构协助下联合组成的医药保健品类科技咨询与进出口贸易服务公司。

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北京宏汇莱科技有限公司 | hwcome.com Reviews
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北京宏汇莱科技有限公司〔Beijing HongwayTechnology Co.,Ltd.〕,是一家在北京清华工业开发研究院支持下,由中青年医药专业技术人员及医药法规专家为骨干,在相关部门和科研机构协助下联合组成的医药保健品类科技咨询与进出口贸易服务公司。
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服务项目,美国fda药品gmp符合性现场检查的准备指导与翻,药品欧洲药物档案 edmf 的编写,药品欧洲药典适用性证书 cos/cep 的申请文,欧洲edqm现场gmp符合性检查的指导准备与翻译,美国fda简略新药申请 anda 及现场的gmp符,欧洲简略新药申请 anda 及现场的gmp符合,加拿大dmf,日本jdmf,印度原料药注册,中国gmp认证的咨询服务,美国,欧盟,中国gmp培训服务,美国药典 usp 的成分认证,进口药品国内注册登记,国外医药卫生类企业与机构在华的商务与政,更多服务项目
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北京宏汇莱科技有限公司 | hwcome.com Reviews

https://hwcome.com

北京宏汇莱科技有限公司〔Beijing HongwayTechnology Co.,Ltd.〕,是一家在北京清华工业开发研究院支持下,由中青年医药专业技术人员及医药法规专家为骨干,在相关部门和科研机构协助下联合组成的医药保健品类科技咨询与进出口贸易服务公司。

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北京宏汇莱科技有限公司

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5 现场工作, 对企业管理人员进行全面系统的GMP培训,包括CGMP 和ICH Q7 GMP的基本原则、主要内容详细介绍; FDA 现场检查六大系统介绍及现场检查的准备; 原料药FDA现场GMP符合性要求与检查实践等;. 6 现场工作,对企业硬件和软件系统进行全面审核,提出硬件改造意见,软件审核意见,必要情况下对企业的文件系统进行全面升级,以确保符合FDA现场检查要求. 12 现场检查结束后,协助完成现场缺陷表 483表 的补充,直至获得现场检查通过确认函。 二、 提供 药品欧美上市申请 准备工作程序的总体安排意见. 三、 对厂区平面布局 图 、生产车间布局 图 、设备平面布局图、仓储及公用设施平. 六、提供欧美GMP法规、特别是美国CGMP 和ICH Q7 GMP的培训,包括现场检查迎检人员的培训,主要培训内容包括. CGMP 和ICH Q7 GMP的基本原则、主要内容详细介绍.

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北京宏汇莱科技有限公司

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北京宏汇莱科技有限公司

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5 现场工作, 对企业管理人员进行全面系统的GMP培训,包括ICH Q7 GMP的基本原则、主要内容详细介绍; 原料药欧洲EDQM现场GMP检查要求与检查实践等;. 6 现场工作,对企业硬件和软件系统进行全面审核,提出硬件改造意见,软件审核意见,必要情况下对企业的文件系统进行全面升级,以确保符合EDQM现场检查要求. 二、 提供 药品欧美上市申请 准备工作程序的总体安排意见. 三、 对厂区平面布局 图 、生产车间布局 图 、设备平面布局图、仓储及公用设施平. 六、提供欧美GMP法规、特别是美国CGMP 和ICH Q7 GMP的培训,包括现场检查迎检人员的培训,主要培训内容包括. CGMP 和ICH Q7 GMP的基本原则、主要内容详细介绍.

4

北京宏汇莱科技有限公司

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美国FDA药品 药物档案 DMF 的编写与登记.

5

北京宏汇莱科技有限公司

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美国FDA药品 药物档案 DMF 的编写与登记.

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