Clinical Manufacturing for Phase I, II and III supplies
• Tablet
• Capsules (liquid in hard gelatin capsule, powder, pellet, beads, etc.)
• API in Capsule
• Sterile
• Liquids
• Gels, Creams
• Matching placebos
• Over encapsulation
Clinical Packaging for Phase I and II supplies
• Primary packaging and Secondary packaging
• Label design, printing and application
• Inventory managementRandomization - Study-specific
• Post-study drug return and reconciliation
• Controlled substances-schedules II, III, IV and V
• Storage and Distribution (Refrigerated and frozen)
• Comparator sourcing and blinding
| 
|
|