Process R&D Services

• Manufacturing platform screening and selection
      Wet vs. dry granulation
      Spray drying vs hot-melt extrusion
      Tablet vs. encapsulation
      Pellet layering vs. extrusion-spheronization
• Process development, scale up and transfer
• Process robustness evaluations
• Definition of CPPs in relation to CQAs and risks
• Establishment of acceptable ranges for CPPs
• Process validation/PPQ study design, execution and documentation