Clinical Registration & Annual Stability Studies

Clinical registration stability studies and annual stability testing are designed to establish and confirm product shelf life under long-term and accelerated conditions. These programs generate GMP stability data that support regulatory filings, label claims, and ongoing quality verification. The accuracy of these studies depends on both controlled storage and consistent analytical execution.

At BA Sciences, we manage long-term stability studies for investigational and commercial drug products using validated methods, controlled material handling, and ICH-compliant stability chambers.

Annual stability testing programs are required to support ongoing product release and shelf-life claims after initial registration. We manage annual studies under defined protocols with sampling plans aligned to regulatory expectations and client SOPs.

All samples are stored in validated ICH-compliant stability chambers with continuous temperature and humidity monitoring. Testing is performed under cGMP and documented using validated LIMS and ELN systems; all chambers are on a back-up generator system to ensure condition continuity.