Demonstrating that every method is fit for purpose

Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. ICH Q2(R1) - Validation of Analytical Procedures: Text and Methodology defines that "The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose".

With extensive method development and validation experience we offer:

• API and Drug Product methods
• Stability indicating methods
• State of the art technology such as UPLC decreasing run time whilst increasing sensitivity
• Compliance with ICH under cGMP quality

We provide analytical chemistry and quality control support for Method Development and Validation in accordance with ICH guidance documents and current Good Manufacturing Practices.

For further information on our Global service offering please email pharmaservices@gen-probe.com