Analytical Development and Quality Control

Our analytical chemists provide comprehensive analytical testing support for process development and drug substance and drug product manufacturing. Our analytical team follows regulatory guidances on supply chain assurance for quality control. The analytical capabilities include platforms of excellence for the following:

• Analytical method development, method validation and qualification
• Analytical technology method transfer
• Reference standard characterization and qualification
• ICH stability studies for drug substance and drug product
• Impurity identification, characterization and profiling
• Genotoxic impurity method development and validation
• Genotoxic impurity lot analysis and COAs
• Trace metal analysis and method development
• cGMP batch release testing for drug substance and product and COAs
• Process control strategies and analytical QC manufacturing supports
• cGMP NMR services for process support and quantitative NMR for API quantification studies
• Formulation solubility, dissolution, disintegration and permeability studies
• Microbial limit test and COAs