Analytical Services
Eurofins CDMO network of companies offers analytical method development & validation services as part of API development as well as stand-alone analytical testing services for projects at various stages in the drug life cycle (pre-clinical to late phase). Our analytical scientists specialize in the development of analytical methods and phase appropriate specifications to ensure control of the synthetic process and quality throughout the program.
Services
Analytical Method Development
- Method Development
- In-Process Controls
- Method Optimization
- Suitability Testing
- Starting Material, Intermediate & API Release
- Impurity Characterization
- Impurity Isolation
- GTI Control
- PGI Control
- Non-Chromophoric Detection (CAD, ELS, MS, RI)
- Specification Development
Analytical Method Qualification / Validation
- Method Establishment
- Method Transfer
- Phase Appropriate Method Qualification
- Method Verification
- Full Method Validation
Standard Qualifications
- Identification Standards
- Physical & Structure Characterization
- Reference Standards
Lifecycle Optimization
- 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
