Analytical Method Development and Validation

Guided by QbD, we provide comprehensive analytical method development and validation in accordance with ICH Q2 based on CQA to support oral dosage form development. We also perform life cycle management to ensure quality research and control provide accurate and reliable data at different drug development stages.

In addition to routine analysis, we support in vitro dissolution method development for insoluble compounds, e.g., amorphous solid dispersion, by understanding the fundamentals of dissolution mechanism, and providing in vitro dissolution data to build the IVIVR research. We also provide genotoxic impurities, elemental impurities and microbial limit testing services.