Overview
Stability data is the clock ticking on your product's commercial viability. We design robust stability protocols compliant with ICH Q1 guidelines and analyze your data to support maximum shelf-life claims. We help you handle excursions, trends, and out-of-specification (OOS) results effectively.
Key Features
Our Process
Protocol Design
Creating efficient studies that cover all necessary conditions and timepoints.
Data Monitoring
Ongoing review of data to catch trends early.
Reporting
Authoring stability reports for annual updates and submissions.
Frequently Asked Questions
Why Choose Us
- Maximized commercial shelf life
- Robust support for storage conditions
- Global climate zone compliance
- Scientific defense of data trends
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Schedule ConsultationWhat Our Clients Say
"Our stability protocol was overly complex and inefficient. Adelphi redesigned it to meet all regional requirements with 40% fewer timepoints. Smart science, better economics."
Tom Richardson
CMC Lead
Global Pharmaceutical
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