Analytical Method Development

• Method development
• In-process controls
• Method optimisation
• Suitability testing
• Starting material, intermediate & API release
• Impurity characterisation
• Impurity isolation
• GTI control
• PGI control
• Non-Chromophoric Detection (CAD, ELS, MS, RI)
• Specification development

Method Qualification/ Validation

• Method establishment
• Method transfer
• Phase appropriate method qualification
• Method verification
• Full method validation

Standard Qualifications

• Identification standards
• Physical and structure characterisation
• Reference standards

Commercialisation Support

• DOE studies
• CPP assessment/support
• Fate of impurities
• Regulatory gap assessment
• CMC support

Stability

• Short term stability studies
• ICH stability studies
• Photo stability (ICH Q1B)
• Forced degradation studies
• Trending studies and reporting