• Environmental clearance
• ETP development
• Technology transfer
• Method validation/verification
• Absence/carryover/spike studies
• Elemental impurities risk assessment
• Genotoxic Impurities evaluation
• Structure elucidation Mass/NMR/IR/UV/XRD/DSC etc.
• HPLC/GC/LC-MS analysis
• Nitrosamine impurities evaluation?