Our custom analytical and bioassay services set our stability studies apart.
Our comprehensive suite of analytical and bioassay development services enables us to provide our clients with validation data and full documentation to meet all cGMP, ICH, and international regulatory authority requirements.
We conduct stability studies to determine shelf life for active pharmaceutical ingredients (API), intermediates, drug products, placebos, and reference standards. In addition, we can design stability studies to meet your specific requirements.
Our stability capabilities and assets include:
- Customer reviewed and approved stability protocols
- QC and QA reviewed Certificates of Analysis provided at each time point
- Capacity to support all ICH long-term, intermediate and accelerated stability conditions
- 24-hour monitoring of all stability chambers and freezers with emergency backup