From discovery through post-approval, analytical development is a critical part of the drug development process occurring throughout all stages with strict guidelines.
With analytical capabilities, scientific expertise and state-of-the-art instrumentation to support all stages drug development, Eurofins BioPharma Product Testing can support the development and validation of virtually any test for your starting material, API, bulk product, finished product, intermediate or packaging under cGMP guidelines.
Having developed thousands of analytical methods using a wide range of technologies, ranging from routine to specialized methods, Eurofins BioPharma Product Testing supports all aspects of analytical development, including:
- Method Establishment
- Method Transfer
- Impurities Testing
- Residuals Testing for Bioprocess Validation
- Comparator Product Testing
- Bioassay and cGMP Potency Testing
- Biosimilar Potency Testing