Analytical Testing and cGMP Stability Services
Stay Focused – Leave the Testing to Us
Partnering
Stability studies require a dedicated effort across long time periods, often tying up resources for years. Partnering with Argonaut gives you the expertise and capabilities you need, without the headaches of managing chambers, storage conditions, or testing; allowing you to focus on pursuing pre-IND submission, clinical trials, or commercialization.
- Dedicated project management
- Quality by Design (QbD) and technology transfer
- Quick response to product development changes
Compliance
Staying current on both FDA and ICH guidelines in changing regulatory environments is a challenge. Argonaut’s stability team can help keep you in compliance and leverage cGMP programs to support your effort in establishing expiry dating for your intermediates and finished products.
- cGMP validated environments with secured storage areas
- Validated Building Management System with backup generator
- 24/7 monitoring
Capabilities
We can satisfy regulatory requirements utilizing real-time, accelerated and freeze- thaw studies. With Argonaut’s fully equipped lab, a diverse range of assessments and methodologies can be engaged- from core characteristics to purity, identity, and potency parameters.
- Assay transfer, qualification, and validation
- Stability protocol generation, storage and testing
- Comprehensive summary reports
- Preclinical through Commercial Stability
