Regulatory Compliance
- Ensure compliance to ICH guidelines and CFRs
- Timely and accurate evaluation of product stability
Stability Chambers
- State-of-the-art validated chambers
- Full range of stability recommended and accelerated storage conditions
- 24-hour monitored facilities with overlapping back-up systems
- Dedicated responsive staff to address alarms and temperature excursions
Stability Testing
- Reliable stability indicating test methods with cGMP testing capabilities
- Scientifically sound and timely method transfers
- Full QC analytical development and qualification/validation
Stability Study Management
- Tailored stability protocol design and sample coordination
- In-house stability testing, sample storage, and data trending
- High-quality and timely technical reports and data summaries
- Timely notification of OOT and OOS results