Method Development & Validation

METHOD DEVELOPMENT SERVICES

PTL’s analytical team is your expert choice for the comprehensive development of dependable particle characterization methods.  Our extensive experience with a wide variety of material types, industries, and analytical techniques, provides a broad knowledge base to facilitate the development of accurate and precise methods for even the most problematic sample types.

A customized testing plan is designed by our statistical team in order to evaluate multiple factors and their potential to impact results.  Refinement of critical factors may ensue, in order to assure that variances are minimized in the final method.  

Clients receive a comprehensive method development report which includes all initial evaluations conducted, corresponding results, statistical summaries, as well as the finalized test method.  Contact PTL today to discuss your method development needs.

METHOD VALIDATION SERVICES

PTL’s validation team has broad and extensive experience conducting particle characterization validations at client request.  Method validations are conducted in conjunction with PTL developed methods or client provided methods.  PTL follows testing guidelines set forth by the ICH, USP, and FDA.  

As your validation partner, PTL customizes a testing protocol designed per your specific quality requirements.  At the conclusion of testing, PTL provides a comprehensive validation report which incorporates the validation data and statistical summary, as well as the final validated method.  Contact PTL’s validation team today to discuss your validation requirements.   

METHOD TRANSFER SERVICES

PTL coordinates and executes method transfer projects both into PTL’s laboratory as well as those transferred to an alternative facility.   Whether your company requires complete oversight of the project, including protocol creation, testing, and report generation, or simply execution of the analytical testing in accordance with your provided protocol, PTL is prepared to participate at any level.   Throughout the method transfer process, PTL will work to assure your quality requirements are upheld.  Please contact PTL today to discuss your method transfer needs.

METHOD VERIFICATION SERVICES

PTL frequently conducts method verifications for our clients, following USP guidelines.  PTL provides a complete verification package, including protocol development, sample analysis, and a comprehensive report.   Contact PTL’s validation team to discuss your specific method verification requirements.

Statistical Analysis 

PTL’s statistical team is able to establish equivalency across samples and instruments through the use of statistics.   We offer a statistical analysis package similarly utilized with our method developments, validations and transfers.  This statistical package provides additional value as it further examines test data, establishing equivalency across testing variations and evaluating the effect of specific factors, thereby optimizing results.

A comprehensive report is provided for each statistical evaluation conducted, including the design used, the results, and statistical conclusions.  Please contact PTL’s statistical team today to discuss how statistical evaluations can be utilized to increase the impact of your data.

Click here to request a quote, or,  for more information about our services, please contact us.