Stability
We offer stability storage at ICH and customised conditions. Our flexible approach means our clients can take advantage of the full range of services or select areas of expertise as required.
Our services include:
- ICH stability storage
- Customised stability storage
- Analytical testing, microbial testing, and technical support throughout the stability study
- Stability-indicating method development and validation
- Stability study design and GMP documentation
- Project mangement
- QP (qualified person) services to assist with regulatory compliance
- IT solutions to support sample management
- Business continuity services
Our walk-in stability rooms and chambers are fully validated to meet GxP regulations.
Our equipment and computer systems, used to control and monitor stability studies, are fully validated in compliance with EU and US cGMP regulations and are 21 CFR Part 11 compliant.
Our storage facilities are purpose built, designed to allow expansion and have controlled access, we also operate a monitored alarm system. Complete emergency back up systems are in place to ensure business continuity, offering clients complete piece of mind
Contact us today to confidentially discuss any upcoming stability projects we can help you with.
