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.

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