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 >>
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Stability Studies
We have all relevant stability chambers for API and formulated product, monitoring both chemical and physical stability. >>
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Method Development
Our method development plan is specific to each technique and product. All methods are documented in detail for straightforward inclusion into >>
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Release Testing
Our Regulated Analytical Lab follows strict cGMP criteria with state-of-the-art instrumentation combined with documented calibration and system suitability procedures >>
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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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