Release and stability services
Corealis provides comprehensive analytical method development and qualification, release testing, stability and storage analysis services for pharmaceutical oral solid dosage (OSD) drug product formulation development and clinical supplies manufacturing.
Analytical services available from Corealis for OSD drug product formulation development and clinical supplies include:
- Analytical method development
- Analysis of prototype formulations
- Stability storage and testing of prototype formulations
- Analytical method qualification for release testing as per cGMP requirements
- cGMP release testing
- cGMP stability storage and testing
- Analytical methods validation for manufacturing cleaning verification
- cGMP analysis for cleaning verification
- Analytical methods transfer to a sponsor-approved cGMP laboratory
