We conduct method validation studies to show that a method is suitable for its intended purpose. We also apply transfer method protocols to ensure that the results obtained by sending and receiving in our laboratories are equivalent within pre-determined acceptance criteria.
Our Method Validation Studies
We develop, validate and publish analytical methods to identify and measure pharmaceutical ingredients according to the European Medicines Agency (EMA) and International Conference on Harmonization (ICH) guidelines.
Method validation aims to demonstrate through inspection that a method is fit for its intended purpose. It means evaluation of performance and uncertainty.
Our quality planning ensures that method validation studies are carried out on optimized and adequately calibrated equipment.
Our qualified analysts are competent in method validation and have sufficient knowledge and experience to observe and evaluate data during method validation.
Our Transfer Method Protocols
We implement transfer method protocols on previously validated methods. This ensures that the results produced by the sending and receiving laboratory on the same samples are equivalent within predetermined acceptance criteria.
Our project coordinator creates the analytical transfer method protocol. In response, our lab manager and QA manager review the transfer method protocol and send it for approval.
EUROLAB, with its highly expert team and internationally accredited laboratories, Method Validation and Transfer It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
