Our Stability Services provide complete, GMP-compliant solutions for the design, management, and execution of product stability programs. We support pharmaceuticals, nutraceuticals, and chemical products across all dosage forms, ensuring compliance with ICH, and other global regulatory requirements. From study design to final report generation, our services ensure product integrity, shelf-life accuracy, and regulatory readiness.
Comprehensive Stability Capabilities Include:
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Stability Study Design & Management
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Development of study protocols in alignment with ICH Q1A(R2) and related guidelines
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Long-term, intermediate, and accelerated conditions
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Custom storage profiles for global market requirements (e.g., Zones I–IVb)
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Ongoing study management with trend analysis and interim data reporting
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Stability Storage Facilities
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Fully qualified and continuously monitored stability chambers
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Controlled environments for temperature and humidity (e.g., 25°C/60%RH, 30°C/65%RH, 40°C/75%RH, etc.)
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Backup systems, real-time environmental monitoring, and validated equipment maintenance
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Segregated storage for developmental, GMP, and retain samples
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Stability Testing Services
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Assay, related substances, and dissolution testing
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Physical, chemical, and microbiological evaluations
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Appearance, pH, moisture, viscosity, particulate matter, and other key attributes
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Execution of all testing per validated methods under GMP compliance
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Study Types Supported
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New product development and shelf-life establishment
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Ongoing (commercial) stability programs
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Registration and regulatory submission studies
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In-use, photostability, and stress testing studies
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Data Management & Reporting
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Secure data handling and complete traceability throughout the study lifecycle
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Generation of interim and final stability reports suitable for regulatory submission
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Trending, graphical representation, and statistical interpretation of results
- Shelf Life Estimation and Advice
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