Our Services
Our expertise is in delivering comprehensive analytical solutions ensuring quality, precision and reliability for our clients. This spans regulatory compliant method development, validation, verification and strategic consultancy services.
Method Development & Validation/Verification
• Analytical solutions including HPLC assay, dissolution, impurity profiling as per global pharmacopoeial standards.
• Expertise across APIs and all formulation types – solid, liquid, semi-solid, and parenteral.
Extractables & Leachables (E&L) Studies
• As per PQRI, USP <1663> / <1664>, USP <661.1> / <661.2>, Ph. Eur. 3.1 / 3.2, ICH Q3D.
• Covering pharmaceutical container-closure systems.
Nitrosamine Testing
- Comprehensive risk assessment, method development & validation, and quantification by LC-MS/MS, GC-MS/MS in accordance with EMA, USFDA, and ICH guidance.
Dissolution & Bio waiver Studies
• Comparative dissolution profiling, solubility & stability evaluation.
• Biowaiver study design and justification in alignment with EMA, USFDA and ICH guidance.
Elemental Impurity Testing
• As per ICH Q3D (R2), USP <232>/<233> and Ph. Eur. 2.4.20.
• Identification & quantification of trace-level elemental impurities using ICP-MS.
Document & Project Management Services
• End-to-end coordination from study initiation to final report delivery.
• Real-time tracking, documentation control, and audit-ready compliance
Analysis of Residual Solvents
• As per ICH Q3C (R9), USP <467>.
• Expertise across drug substances, excipients, and finished drug products.