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无论您是需要帮助识别具体问题的潜在原因,还是需要协助审核分析和临床数据,我们的专家都能帮助您克服产品生命周期中的各种挑战。凭借深厚的科学经验,我们的专家随时准备协助您与当地卫生部门沟通,或提供实际的故障排除服务。

咨询

咨询

咨询

通过让专家审查失败的生物等效性研究的分析和临床数据,降低下一步开发步骤的风险——或者根据GMP审核结果获得指导,以确定行动方案。

 

Have professionals evaluate the analytical and clinical data from a failed bioequivalence research to reduce the risk associated with your next development steps, or seek advice on how to define actions based on the findings of a GMP audit.

培训

培训

培训

无论您是想了解更多关于GMP、体外溶出方法开发、良好溶出操作还是IVIVC的知识,我们的专业培训课程都可以根据您团队的具体需求进行调整。

 

Whether your staff needs to learn more about IVIVC, Good Dissolution Practices, GMP, or in-vitro dissolution technique development, our expert training courses can be tailored to meet their needs.

调查

调查

调查

从故障排除到不符合规格 (OOS) 的调查,我们的团队会在您产品的整个生命周期中协助您识别可能的根本原因并实施针对特定问题的解决方案。

 

Throughout the lifecycle of your products, our team helps you find potential root causes and put solutions in place for specific issues through troubleshooting and out-of-specification (OOS) investigations.

Q1/Q2监管审批

Q1/Q2监管审批

Q1/Q2监管审批

我们在指导仿制药公司完成向监管机构证明其产品在定性和定量上的一致性以获得生物豁免方面拥有丰富的经验。

 

We have extensive expertise working with generic companies to help them demonstrate both qualitative and quantitative sameness to regulatory bodies in order to get a biowaiver.

审计

审计

审计

让我们作为独立权威机构对您的制造和测试承包商进行审核——或者由经过认证的专家对您的分析数据进行技术审核,以确认其合规性。

Allow us to conduct an impartial audit of your manufacturing and testing contracts, or arrange for technical audits of your analytical data to verify compliance, conducted by qualified subject matter experts.

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