GMP Analytical development and validation services

Our state-of-the-art laboratories offer a wide range of analytical services to support your exact needs under strict quality procedures which meet GMP requirements and following ICH guidelines. The analytical department provides support during the development of drug formulations combining modern instrumentation and the advanced knowledge in the field of analytical science as well as validation services across a range of analytical activities. The instrumentation used follow the GMP requirements, such as the annual operational and performance qualifications as well as the requirements for computerised systems and data integrity. Lamda's analytical options are available on a stand-alone bases or as part of a full development package. Analytical Services Examples of the analytical services we offer include: Analytical method developmentAnalytical method validationForced degradation studiesPhotostability studiesDevelopment and validation of dissolution methodsRegistration and post approval stability studiesIn use stability studiesProcess validation studiesMethod transferDrug Product release (EU QP release)API controls