Analytical Chemistry methods are key to ensuring the quality and identity of your product. Eviva Pharma have experience of the analytical chemistry work required during each phase of your product’s development including:
- Development of stability indicating methods
- Assessment of method suitability
- Pre-formulation and excipient compatibility studies
- Troubleshooting problems with analytical methods
- Stability study design
- Forced degradation work
- Photostability assessments
- Method validations
- Method transfers
- Generation of batch analysis data
- Certificates of analysis
- Generation of reference standard characterisation
- Specification setting
- Release testing
- Support in the preparation of analytical sections of CMC regulatory documents
Eviva Pharma can help design studies to ensure compliance with ICH guidelines and can review data to confirm it is clear, reliable and compliant.
Eviva Pharma have experience of both small molecules and biological products and have worked with numerous contract laboratories to ensure the correct tests are being performed at each phase of the project.
Eviva Pharma have experience of many analytical chemistry techniques including, but not limited to, HPLC, dissolution, IR, GC, KF, LC-MS, UV spectrophotometry, SEC, ELISA and electrophoretic techniques.
Please contact us to see if we can help with the analytical development of your product.