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当前位置 > 技术服务 > 生物研发服务> 其他生物研发 > cGMP分析服务
cGMP分析服务
药物稳定性考察;方法建立;测试发布;方法验证
服务类别:其他生物研发总访问:805
最后更新:2013-8-8半年访问:69
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服务商: 苏州晶云药物科技有限公司 查看该公司所有服务 >>
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Analytical methods should be developed quickly but with sufficient sensitivity to control impurity profiles in drug substance or degradants in drug product. We have extensive experience in efficiently developing and validating quality methods, as well as release of clinical materials, stability studies and analytical investigation on key issues during drug product development.

Drug Product Development


We provide a wide variety of analytical services to support every stage of drug product development. We will work with you to support all   >>

Stability Studies


We have all relevant stability chambers for API and formulated product, monitoring both chemical and physical stability.   >>

Method Development


Our method development plan is specific to each technique and product. All methods are documented in detail for straightforward inclusion into  >>

Release Testing

 

Our Regulated Analytical Lab follows strict cGMP criteria with state-of-the-art instrumentation combined with documented calibration and system suitability procedures  >>

Method Validation


Method validation must adhere to criteria outlined in regulatory documents such as ICH Q2. Our scientists have the expertise   
>>

 

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