
Services offered:
i. Analytical Development- Analytical Method Development & Validation
- Cleaning Residuals Validation
- Dissolution and Drug Release Profile
- Stability Monitoring
ii. Pre-formulation
- Physical Properties
- Powder Characterization
- Forced Degradation Studies
- Compatibility Studies
iii. Formulation Development
- Prototype Formulation
- Preliminary Process Development
iv. Clinical Trial Manufacturing & Scale-up
- Process Optimization
- Scaling up
- Clinical Trial Manufacturing
- Commercial Product Manufacturing & Process Validation
v. Stability studies
- ICH conditions
- Studies & Reporting
vi. Registration support
- Validation Protocols & Reports
- Documentation Support
- CTD writing
- Registration Strategy Development