We do all these analyses in a regulatory environment pertaining to your phase of development from preclinical-phase characterisation studies through to Good Manufacturing Practices (cGMP) and beyond.

• Structural Characterisation (ICH Q6B) • Physicochemical Properties (ICH Q6B) • Biophysical Characterisation

• Comparability Studies

• Process Residuals Determination

• Product Related Impurities Determination

• GMP Potency / Cell Based Assays

• Method Development & Validation

• GMP Quality Control Testing

• GMP Batch & Final Product Release Testing

• ICH Stability Studies

• Forced Degradation Studies

• Drug Delivery / OINDP Expertise