Enhance the shelf life of your drug product and ensure regulatory compliance with our stability testing and storage services. Our team manages state-of-the-art laboratories equipped with stability storage chambers mapped and continuously monitored using a validated, continuous monitoring system. These facilities fulfill requirements for stability studies, shelf-life testing, and shelf-life determination, whether we follow client-supplied methods, compendial methods, or methods developed and validated by our own analysts.
We support studies for both short-term (accelerated) and long-term stability programs as well as photostability programs for both research and development and commercial products.
Our chambers and monitoring system are supported by external back-up power generators in the event of power failure. Although our stability storage capabilities are geared toward providing pharmaceutical and biopharmaceutical stability storage, we also provide stability storage on medical devices and other types of products.
Prepare your product and packaging for freeze thaw cycling with stability studies powered by our expert team. The various environmental conditions your product is exposed to during shipping and storage have the potential to compromise overall stability and return it to the base state. Our team helps you predict possible outcomes by designing and executing freeze thaw studies, giving you confidence that your product will not be compromised by fluctuating temperatures.
Satisfy ICH Q1B standards with expert photostability testing for your drug product. Photostability studies are performed as part of forced degradation studies, product development, or product investigation and complaint handling. We employ photostability chambers that are temperature-controlled with calibrated UV and visible light sources. These studies are executed based on your internal protocol or protocols drafted by our team. When drafting protocols, our team outlines your product’s exposure needs and the chemical and/or physical testing necessary to fulfill your product’s photostability testing needs.
Ready to Get Started? Connect with our team to discuss your testing and development needs.
