Our state-of-the-art analytical laboratory supports the entire drug development lifecycle, ensuring robust data integrity, accuracy and compliance with global regulatory expectations.
Comprehensive Analytical Services
Method Development & Validation – Custom analytical method development for assay, dissolution, impurities, and degradation studies.
Stability Studies & Forced Degradation – Conducting long-term, accelerated, and in-use stability studies per ICH guidelines (Zone I to Zone IV and so far).
Raw Material & Finished Product Testing – Ensuring identity, purity, potency, and microbial safety.
Dissolution & Bioequivalence Support – Critical studies for bioavailability and pharmacokinetics assessment.
Advanced Analytical Techniques
Chromatography & Spectroscopy – HPLC, UPLC, GC, LC-MS/MS, ICP-MS, and NMR for precise characterization.
Elemental & Impurity Profiling – Nitrosamine risk assessment, genotoxic/teratogenic impurity assessment and ICH Q3D compliance.
