MTR’s pre-formulation services are fully supported by comprehensive and state of the art analytical capabilities. Our in-house GLP facilities are geared up to carry out the full array of activities to support client requirements for development and approval.
Services
- Analytical method development and validation (ICH guidelines)
- Raw material and reaction monitoring
- Stability studies for API (ICH guidelines)
- Material evaluation for preclinical and clinical studies
- Impurity profiling and characterization
- Preparation of reference and working standards
- Analytical support for drug master filing
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