Process R&D Services

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