We offer a full range of stability testing and storage services to meet the performance needs of our clients. Our stability operations include 15,000 cubic feet of walk-in/reach-in chambers/incubators at our affiliate parent company, Neopharm Labs. The GMP facility in Montreal meets the ICH guidelines requirements for stability testing services. We also support special storage conditions customized to a client’s specific needs. A dedicated staff and specifically designed software provides total management of stability programs including timely reports, interpretations and recommendations.
Our team includes industry veterans with significant regulatory experience capable of assisting clients with respect to assessing requirements and developing:
- Stability programs in accordance to ICH Q1A, WHO and other regulatory requirements
- Regulatory compliance for Canada, US, Europe and Asian markets
- Design of customized Global stability testing protocols to support drug registration and to satisfy all regulatory requirements as per ICH Q1A and WHO Stability guidelines
- Matrix and bracketing designs for reduced stability testing of commercialized products as per ICH Q1D
- Projection of shelf-life with fully validated software for world wide regulatory submissions with 95% confidence limits and ANCOVA calculations according to ICH Q1E guideline
- Stability packages as per SUPAC to support post market changes such as manufacturing site, container/closure, and product formulation changes
- Annual reports including tabulation of results and graphical trend analysis by a validated statistical software respecting FDA SAS program