Method Development and Validation
Our highly skilled method development scientists are primed and ready to help you reach your next development milestone. With a range of advanced analytical technologies and innovative instrumentation, we are skilled in developing efficient, accurate, reliable analytical methods.
We have the technical capabilities to develop and validate a wide variety of analytical methods for small molecules and biologics in either the liquid or solid state. We can also transfer developed methods to your production site, optimizing your processes and helping to ensure a successful validation.
Underpinned by precision and quality, we support the four most commonly required methods for various stages of drug development:
- Identification tests
- Limit tests
- Assays
- Quantitative analyses
We develop and validate methods according to the International Conference on Harmonisation (e.g., ICH Q2(R1), Q2B, and Q6A) and FDA guidelines.
Analytical techniques
Leverage the experience of our expert chemometricians who design appropriate experimentation for developing complex methods requiring principal component analysis (PCA) or partial least squares (PLS) regression if necessary.
Our highly skilled scientists also have significant experience in detecting and quantifying minor amounts of amorphous or crystalline forms in both drug substances and drug products.
Our experts have access to a comprehensive range of analytical techniques.
- LC
- MS
- NMR
- XRPD
- IR
- Raman
- Thermal analysis
- Vapor sorption
- Particle size
- Microscopy