Analytical Development
Chemical and Formulation Development Support
- Analytical methods development and validation
- In-process control method development
- Starting material and raw material testing
- Impurity profiling
- Impurity isolations and characterization
- Degradation product characterization
- Compatibility testing
- Accelerated, intermediate and long term stability and forced degradation studies
- Dissolution testing
Release Testing for Drug Substances and Drug Products
- Methods development and validation
- Purity assay
- Total related substances
- Dissolution and content uniformity
- Residual solvent quantification
- Moisture content assessment
- Counter-ion determination
- Compendia testing for elemental impurities, ROI, and LOD
- Physical property measurement
- Impurity and degradation product structural identification
- Microbial limit tests(Ch.P&USP)
- Documentation and Issuance of COA’s
Reference Standard Qualification as per ICH Guidelines
Accelerated and intermediate long term stability study as per ICH Guidelines
- Service Overview
- Discovery Chemistry
- Biology & Pharmacology
- DMPK / Exploratory Toxicology
- Biologics Discovery
- Biologics CMC
- Small Molecule CMC