We provide full ICH studies and on-going stability programmes for third parties. These services, at the client's request, can include: method transfer, method improvement, analytical standards management, storage at different conditions, scheduling of analytical timepoints, full analysis and out-of-trend (OOT) and out-of-specification (OOS) management. These tasks are always conducted according to procedures agreed upon with the client.
If the analytical methods are not available, we can perform stress testing (light, pH, humidity, temperature and oxidation) and development and validation of stability indicating methods.
