Our laboratories are at the forefront of conducting in-depth stability and excipient compatibility studies. These critical analyses, including Accelerated and ICH Stability Studies across various climatic zones, are pivotal in predicting the shelf-life and ensuring the safety and efficacy of drug products. 

In addition to conventional real-time stability studies, we can also predict the long-term stability by means of mathematical accelerated stability assessment tools applied on short term incubations at elevated temperatures and humidity conditions.

When all methods in scope are developed and optimised, they are then subjected to a R&D pre-validation. This R&D pre-validation has the following intentions:

Demonstrating confidence in the methods for further usage in the R&D environment (e.g. for R&D accelerated stability studies).

De-risking and facilitating the transfer of methods from our R&D entity to our GMP QC entity for subsequent validation, release and stability testing activities in a GMP environment, ensuring timelines are kept.