CiVentiAnalytical offers method validation in a GMP/GLP laboratory setting according to FDA and ICH guidelines. Our experienced analysts will design and execute method validation experiments according to your specifications. When coupled with our method development service we can use statistical models of the separation to do accurate robustness calculations and if there are several methods that will work chose the most robust for validation.

CiVentiAnalytical uses CFR 21 part 11 compliant software integrated into our chromatography data system to streamline the validation process. This eliminates the need to export the data to other programs for processing and automates the programming of experiments saving time and reducing the opportunities for errors. The end result is a detailed validation report appropriate for regulatory submission in less time.

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