Methods Development and Validation

Thanks to the laboratory's expertise, acquired and greatly increased over the years, as well as the provision of dedicated teams, we are able to offer method development and validation services in compliance with ICH guidelines.

The aim is to best understand the customer's needs and requirements in order to offer the best solution by choosing the most suitable analytical technique. 

Method validation is set up in agreement with the customer and following the ICH Guidelines.

The proposed parameters are: specificity, linearity, accuracy, instrumental precision, repeatability, intermediate precision, LOQ, LOD, robustness, stability of standard and sample solution. 

LabAnalysis will draft the validation protocol. Once the customer has approved the protocol, LabAnalysis will perform the method validation. This will be followed by a final report with the results obtained. 

LabAnalysis can support customers in the transfer of analytical methods, with activities similar to those performed for validations.