Projects
Project Examples with Technical Milestones:
- Small molecule in preclinical phase
Quality target product profile - Salt & polymorphic form definition - Route of synthesis - Specifications
- Large molecule for clinical phase 2
Supplier selection - Dosage form definition - Clinical packaging and release
- Tablet to be scaled-up for market launch
Quality-by-design - Process validation - Regulatory dossier preparation
- Capsule trouble shooting
Process review - Failure mode and effect analysis - Risk mitigation - Control strategy