Defining the Shelf Life and Storage Conditions of Your Product
Stability testing verifies that a product maintains efficacy, safety, and quality throughout its labeled shelf life under defined storage conditions. It is a core requirement for all regulatory submissions and market approvals.
Our cGMP-validated stability chambers operate under precise temperature and humidity controls aligned with ICH Q1A (R2). We conduct accelerated, intermediate, and long-term programs to define real-time shelf life and validate expiry labeling.
BQCIS partners with formulation and regulatory teams to design study protocols, manage pull points, and perform analytical testing—assay, dissolution, degradation, and impurity monitoring—producing defensible data packages for global submission.
Key Stability Program Services
Key Benefits of Stability Studies
Define Reliable Shelf Life
Predicts and verifies product longevity under ICH-defined conditions, ensuring accurate expiry dating.
Ensure Global Regulatory Compliance
Programs designed to meet FDA, EMA, and WHO expectations, facilitating international registration.
Maintain Product Quality
Continuous monitoring detects early degradation or impurity trends, protecting therapeutic efficacy.
Accelerate Time-to-Market
Accelerated and predictive data supports early submission and rapid approval, reducing development timelines.
Success Story
Accelerated Stability Data Supports Early Market Launch
A biotech client required rapid stability evidence to support early regulatory submission for a biologic drug candidate.
BQCIS executed an accelerated stability study under 40°C/75% RH, applying high-sensitivity analysis to track potency, degradation, and physical changes, aligned with ICH Q1A (R2).
Within six months, data validated a 24-month provisional shelf life. The early report enabled expedited market authorization—six months ahead of schedule—securing a key competitive advantage.