Stability storage involves placing products under controlled environmental conditions to assess how their quality changes over time.
Broughton provides stability storage services that safeguard product quality, support shelf-life claims, and generate data for regulatory compliance, product development, and commercial readiness.
Our GMP-compliant chambers offer long-term, intermediate, and accelerated storage conditions in line with ICH guidelines.
Provision of long-term, intermediate, and accelerated storage conditions under ICH Q1A standards. Our temperature and humidity-controlled chambers evaluate product stability under real-world and stress conditions.
Custom Storage Profiles
Support for bespoke conditions, including refrigeration, frozen, ultra-low, and client-defined conditions. Suitable for novel formats and non-standard formulations requiring tailored handling.
Photostability Testing
Execution of light exposure studies to ICH Q1B standards. Ideal for assessing degradation risk in products with light-sensitive components.
Transit Simulation
Short-term variable condition storage to model transportation and supply chain fluctuations. Helps determine product robustness and labelling requirements.
Real-Time and Accelerated Study Management
Project management for long-term and rapid-stability programmes, supporting early product development and post-approval requirements.
Validated Data Capture and Reporting
Secure data handling through our Laboratory Information Management System (LIMS) for full traceability, regulatory compliance, and audit readiness. Outputs are formatted for Common Technical Document (CTD) submissions or internal quality frameworks.
Broughton delivers stability storage programmes trusted by regulators and industry leaders. Our integrated service model ensures efficiency, scientific depth, and audit-ready results.
Regulatory Confidence GMP-compliant storage aligned with ICH, MHRA, EMA, and FDA requirements
Scientific Depth In-house expertise across analytical chemistry, toxicology, and regulatory science
Integrated Solutions Combine with stability testing, analytical method development, or batch release for end-to-end support
Agile Delivery Customisable studies, responsive timelines, and dedicated account teams
