Methods Development and Validation

Thanks to the expertise of the Laboratory, acquired and significantly increased over the years, as well as the preparation of committed teams, we are able to offer methods development and validation services.

Aiming at better understanding the problems and needs, once established the Customer's requests, through direct dialogue and technical support, and based on the current regulations / guidelines, LabAnalysis will develop specific methods, with the use of classical techniques (HPLC-UV, GC-FID, ICP-AES, AAS, Etc…) or more innovative techniques (ICP-MS, LC-MS, LC-MS / MS, LC-HRMS, GC-MS / MS).

The developed methods are thus validated.

The validation activities of analytical methods are carried out in accordance with the requirements of the most common ICH guidelines (the parameters frequently evaluated are specificity, linearity, accuracy, instrumental precision, repeatability, intermediate precision, limit of quantification, limit of detection, robustness, stability and system suitability) or specific requests by the Customer or specific requests from regulatory entities. The approach proposed by LabAnalysis consists in drafting the validation protocol that is shared with the Customer for approval, followed by the validation activity. After the statistical evaluation of the data obtained, LabAnalysis always takes care of drafting the final validation report, which will also be shared with the customer.

LabAnalysis can support the Customers with the analytical method transfers, with activities that are similar to what is reported for validations.

Market

Methods Development and Validation