Your One Source Validation Company
面向制药工业的验证服务

We provide qualification and validation services in accordance with FDA and EU GMPs

我们按照FDA和欧盟的GMP规范提供确认和验证服务：

-  Qualification/Validation Services  验证服务

-  Validation Master Plan  验证大纲

-  IQ/OQ/PQ Protocol Preparation   IQ/OQ/PQ方案准备

-  Execution/Report of IQ/OQ/PQ   IQ/OQ/PQ的执行/报告

-  Process/ Cleaning Validation   工艺验证/清洗验证

-  Retrospective Validation  回顾性验证

-  Computer Validation   计算机验证

-  Computer Controlled Systems and Software Validation   计算机控制系统和软件验证

-  21 CFR Part 11 Compliance Audits   21 CFR Part 11符合审计

Consultancy Services on Regulatory and Compliance

GMP规范方面的咨询服务

Served at multinational pharmaceutical and engineering companies for decades,  our consultants can provide following services according to international standard: 

曾在跨国制药及工程公司服务多年的技术专家,按照欧美规范提 供以下咨询服务：

–   Feasibility Study   可行性研究

–   Concept Design   概念设计

–   Design Review/Design Qualification   设计审查/设计确认

–   GMP Consulting   GMP咨询

–   GMP Training   GMP 培训

–   Corporate Compliance Audits  公司规范一致性审计

–   Batch Record Review   批记录审查

–   Regulatory and Compliance Consulting  管理和与规范一致性咨询