Stability Profiles

During the stability stage, we are developing stability information that are added to the comprehensive documentation we prepare for each project. We even produce interim stability reports for clients to submit to the FDA. And, as part of the comprehensive services we offer, we conduct all stability testing in-house, saving development time and costs.

Bio-Concept is equipped with precisely controlled environmental chambers to simulate long-term temperature and humidity conditions according to ICH or FDA guidelines. In addition to the traditional accelerated stability studies, we perform rapid degradation profiles of samples to quickly assess the product options. All of our chambers are connected to an outside alarm service for emergency notification.