Batch Release and Stability Lot Testing
With a strong history of delivering regulatory compliant API, IMP or finished products batch release testing, we are committed to providing the resources and flexibility you need. We quickly develop and improve analytical methods tailored to your specific requirements to meet exacting product specifications.
Our highly qualified laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer. We apply a wide range of innovative analytical technologies across various procedures for the following:
- Drug formulations
- Personal care products
- Raw materials
Our batch release and stability testing scientists work under strict compliance with cGMP requirements and base our optimized operations on detailed SOPs and stringent quality assurance practices.
- Developmental and packaging studies
- Stability protocol design
- Chromatographic analysis
- Wet chemistry
- Dissolution testing
We collaborate closely throughout your project. You’ll receive a comprehensive report that details the procedures, analytical method, protocols, all test results, graphs, calculations and sample raw data.
Wherever you are in the world, our goal is to exceed quality, safety and regulatory standards for your batch release and stability testing needs.