- Analytical method development and validation (ICH Q2)
- HPLC, UPLC, GC, GC-MS, LC-MS/MS, and CE techniques
- Impurity profiling, quantitation, and structural elucidation (qNMR, HR-MS)
- Residual solvents and elemental impurities (ICH Q3C / Q3D)
- Dissolution, content uniformity, assay, and potency testing
Delivers validated analytical methods for qualitative and quantitative assessment of APIs and formulations, ensuring data accuracy and regulatory alignment.