Comprehensive stability testing from a single, dedicated source
Solvias offers efficient, comprehensive stability studies in accordance with ICH guidelines. With our deep expertise, large storage capacity, and flexible approach, we deliver fast, accurate results.
Unique combination of benefits
- Expert staff can develop and validate all stability indicating methods
- Dedicated project management providing insights and support at every step
- Specialized infrastructure with large on-site storage and secure, monitored facilities
- Comprehensive range of analytical services from a single, trusted partner
- Proven track record with 20+ years of experience and 600+ stability programs under our belt
Stability studies for every stage of development
At Solvias, we perform stability studies for small molecules, biologics, and cell and gene therapy programs at every phase of the development cycle:
- API stability testing
- Excipient compatibility studies
- Preclinical and clinical formulation stability
- DS and DP stability
- Stability of reference standards
- Registration stability (final packaging product stability, long-term stability data, in-use stability testing)
- Annual product monitoring
- Post-approval changes
Comprehensive service solutions
We provide a wide range of stability study services in accordance with ICH guidelines for drug development (Q1A-F and Q5C) and follow-up studies.
- Intermediate and long-term stability testing
- Accelerated stability testing
- Forced degradation studies/stress tests
- Photostability testing
- In-use testing, freeze-thaw cycles
- Temperature cycle tests
- Comparative stability testing
- Comprehensive extractables and leachables capability
State-of-the-art facilities
Our fully calibrated and traceable storage chambers are located on-site, and equipped with 24/7 monitoring and alert systems. We also offer custom storage solutions upon request.
