PaizaBio offers a full range of analytical services, utilizing AUSIA Biotech’s extensive laboratory facilities for testing, validation, analysis, and development. Our analytical testing is primarily focused on the analysis of the API/ABI active ingredients and characterization, during and after manufacturing to ensure the integrity of the finished product. AUSIA Biotech has developed and validated its analytical techniques following established industry guidelines. These include:
- Compendia testing According to CFR, USP, NF, EP, JP, AOAC and other standards
- Technical transfer and validation of analytical methods
- In-process testing
- Biological assays
- Finished product testing and release
- Stability study development and management including testing and storage according to ICH guidelines
We follow Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (cGMP) and are ISO 17025 compliant.