METHODS

We can develop a comprehensive set of custom-made, orthogonal methods for identity, quantity, potency, purity and impurity, including product- and process-specific impurities and contaminants to fully monitor product quality at all times.

We help you focus on the objective of each method and provide robust tools with the accuracy and precision you need to track any critical quality attributes (CQAs).

We thoroughly evaluate each aspect of your method through performance verification, including sample preparation, specificity, linearity, LOD/LOQ, range determination, accuracy, precision, recovery and robustness testing, all of which will ensure that your methods are GMP-ready.

We deliver a comprehensive development report & final method with acceptance criteria in line with method performance and help you transfer your new methods to your C(D)MO partner or your GMP CRO of choice.