Process Development

• Meet Client Program needs
  • Manage Expenditures Consistent with Project Reqirements
  • Plan for Scientific and Economic Ends
• Validation and Commercialization Support
  • Registration Lots
  • Validation Lots
  • Documentation Support

Process Development Deliverables

• Technical Evaluation
• Generation of Comprehensive Development Plan
• Statistical Experimental Design
• Mechanistic and Kinetic Studies
• Critical Process Parameters and Quality Attributes
• Proven Acceptable Ranges (PAR)
• Process Sensitivity Studies
• Hazards Evaluation
• Waste Minimization / Solvent Recycling
• Environmental / Industrial Hygiene Assessment
• Raw Material (Supplier) Evaluation and Qualification
• Cleaning Procedures
• Optimization of Unit Operations / Process Controls
• Equipment Configuration and Construction Materials Evaluation
• Final Process Definition
• Evaluation of Solid State Drug Substance
  • Micromiretics
  • Solvation
  • Crystal Habit
  • Polymorphism
  • Physical Handling