Monitoring and evaluating the biophysical and biochemical properties of a drug product over time are critical for regulatory and marketing purposes. We provide the complete range of ICH stability conditions and stability indicating test methods to assure the accurate profile of your biopharmaceutical product.

We routinely perform accelerated and long-term stability studies in support of safety studies, clinical trials and commercial product – from writing the protocol to delivering a technical document ready to be placed into your regulatory submission.

• Protocol development for stability testing
• Design of studies and pull schedule
• Cumulative reporting and trend analysis
• ICH/cGMP stability programs for clinical and commercial products
• Full analytical development, qualification/validation, and cGMP testing capabilities
• COA generation and issuance
• 24-hour computer-monitored facilities
• Photostability testing under ICH Q1B conditions
• Determination of retest dates and expiration dates
• Submission-ready reports