R&D Services

Stability Studies

We perform stability testing for drug substance and drug product in accordance with the International Conference on Harmonisation (ICH) guidelines to support your product.

Our stability study services include:

• Long term stability studies according to International Conference on Harmonisation (ICH) Q1A guidelines
• Accelerated, Realtime and Stress temperature studies
• Repeated freeze/thaw stability
• Certificate of Analysis provided at each time point
• Stability plan determined in conjunction with customer requirements
• Final Certificate of Analysis (CoA) provided at the end of the study