We support your project with analytical method development, method validation, and analytical transfer. Our analytical scientists are highly trained in the relevant ICH Guidelines, e.g., Q1 Stability, Q2 Analytical Validation, and Q3 Impurities. We have extensive experience and knowledge in the analytical requirements from early development all the way to late-stage development. Our experience enables us to quickly set up an analytical method that can be used to evaluate the feasibility of your product.
When the project is going to late-stage development, we will effectively set up validation protocols, conduct trials, report, and ensure that the methods developed to suit the intended use. We use powerful software, e.g., JMP by SAS, for Design of Experiments and statistical evaluation of the obtained data. This shortens the time in every stage of development. Using the resources in the most effective way will make your project reach your goals in the shortest possible time.
