Stability Studies
Our product stability testing program includes documented protocols for the proper handling, storage, retrieval and testing of all on-study material.
Our capabilities
ICH-Compliant Storage and Testing for Long Term and Accelerated Stability Studies
We have a long track record of stability services that are proven reliable for pilot formulations, clinical batches and marketed products. Our technical and regulatory experts can help design your product stability testing according to industry standards and your product-specific requirements.
- ICH-compliant GMP storage
- Accelerated, in-use, short-term and long-term stability programs
- Temperature- and humidity-controlled
- Continuous monitoring, 24 hours a day, 365 days a year
- Validated procedures for handling, storage, testing & dispositionials and syringes
Our facilities
Stability Studies for Global Regulatory Requirements
We maintain dedicated, controlled-access stability chambers for all ICH storage conditions, with alarmed security and continuous monitoring. All recording and calibration devices are routinely calibrated to ensure their accuracy and performance.
Related Services
Analytical Services & QC Testing
Method development, validation and testing
Labeling, Storage & Distribution
ICH-compliant GMP storage. Global distribution
Commercial Manufacturing
GMP Drug Product Manufacturing for International Markets
How Can We Help?
Let us apply our 37+ years of experience to help you solve your development and supply challenges. Learn more about what it means to differentiate your development process with Pyramid Pharma Services.