Method development and validation
When it comes to validating the proportions of active agents, purity or other criteria, just one conclusion is often not enough. For accurate and reliable declarations based on Good Manufacturing Practices (GMP), often the path is the goal. We have developed a multitude of successful methods during the course of our work – together with the necessary methods for its validation in accordance with ICH Guidelines. Naturally, upon request, we will develop innovative and/or individual methods for your specific project. Our reports are optionally available in German or English.
A validated analytical method is extremely valuable. Any change in a laboratory requires complete concentration and meticulous compliance with specifications. In addition, scientific findings keep changing so that we have to steadily develop new methods to improve the quality of our analyses. In both these cases we provide the method transfer, from concept preparation through to actual change. In this regard, we address your specifications and the legal requirements as well as advances in technology that, for example, lead to improved efficiency.