Our multiple, well-fitted laboratories support our drug development program with analytics and extensive quality control programs to meet or exceed FDA compliance standards. From pre-formulation to commercialization, our laboratories support every aspect of your project.
Analytical Method Development
Assessment for Small and Macromolecules
Stability-Indicating Assays
Chromatography by HPLC
Robustness
Gas Chromatography
UV-VIS
Refractive Index
IR Spectroscopy
Wet Chemistry
Extractables and Leachables
Dissolution Studies
Solution Stability
Filter/Flush Evaluation
Method Precision (intermediate and reproducibility)
Limit of Detection
Limit of Quantitation
Linearity and Range
Specificity, Including Forced Degradation Analysis