Preformulation studies

• Active princple characterization
• Production of batches on laboratory size
• Pilot batches manufactoring
• Industrial scale-up
• Process validation
• Production process optimization
• Packaging material evaluation
• Cleaning validation studies

Scale-up

Process validation

Analitycal development

Development of analytical methods, in accordance with I.C.H. guideline
Dissolution studies and pharmaceutical products release curves
Residual solvent evaluation and validation of analytical methods
Raw materials analysis and characterization
Stability studies in accordance with I.C.H guidelines

Studi di scalabilità On-Going e secondo I.C.H.

Development of analytical methods
Stability studies

Production of batches on laboratory size
Pilot batches manufacturing
Industrial scale-up