Enteris has the expertise to provide end-to-end analytical support including analytical method development and validation.
Our analytical team has extensive knowledge of current and evolving FDA and ICH guidelines, and apply a risk-based, phase-appropriate approach to cGMP analytical activities along with industry leading analytical method development and analytical validation.
We provide analytical support to our clients for all stages of drug development, from early characterization of drug substance and solubility screening to stability studies and process validation.
- Physicochemical characterizations of the drug substance
- Solubility studies
- Excipient compatibility
- Forced degradation studies
- Identification of impurities
- Container/closure screening and selection
- Stability studies
- Full support through analytical method transfer
Differentiated Analytical Expertise:
- Analytical method development, verification, qualification, and validation
- Extensive knowledge of FDA and ICH guidelines