DETAILS DESCRIPTION
Analytical R & D
- Position :
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
cGMP batch release testing for drug substance and product and COAs
Process control strategies and analytical QC manufacturing supports
Formulation solubility, dissolution and disintegration studies
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