CapEval Pharma can provide analytical strategies in accordance with ICH standards and develop approaches for pre-clincial and clinical product development. 

We can help in the following areas:

• Method development for API, impurities, genotoxic impurities
• Development of validation protocols according to clinical phase or to ICH standards
• Development of stability indicating methods
• Impurities analysis -related substances, degradants and qualification
• Reference standard qualification
• Stability testing and data interpretation
• Analytical method transfer and validation
• Quality control
• Setting specifications
• Rapid bioanalysis – solid method development/sample analysis for complex approaches (e.g. cassette PK, tissue analysis)
• GLP bioanalysis – method development/sample analysis under compliance with focus on ruggedness
• Metabolite identification and bio-synthesis approaches

Specialities and Expertise:

• Chromatographic separation (GC, HPLC, IC) and derivatization methods
• ICP
• Identification tests (NMR, IR, MS)
• GC/MS and LC/MS technologies (triple quad, ion trap, TOF)
• Genotoxic impurities
• Polymorphic studies
• Lipid analysis (total and free cholesterol, bile acids)
• Isolation/characterization of metabolites using radiolabels