Sample Workflow: From Protocol Design to Submission-Ready Report<\/h2>\n
1. Protocol Development<\/strong>
\n\u2192 Strategically designed stability protocols aligned with ICH guidelines, customized to your product\u2019s formulation, packaging, and regulatory path.<\/p>\n2. Sample Receipt & Controlled Storage<\/strong>
\n\u2192 Immediate logging and placement into qualified stability chambers under GMP-controlled conditions to ensure sample integrity from day one.<\/p>\n3. Stability Testing at Defined Intervals<\/strong>
\n\u2192 Execution of drug stability testing at ICH-specified timepoints, using validated, stability-indicating methods.<\/p>\n4. Data Analysis & Quality Review<\/strong>
\n\u2192 Rigorous data evaluation, statistical analysis, and QA oversight to confirm regulatory compliance, accuracy, and consistency.<\/p>\n5. Comprehensive Report Delivery<\/strong>
\n\u2192 We provide stability study reports with complete data sets and, when infrastructure is in place, can input results directly into the customer\u2019s LIMS system.<\/p>\n<\/div>Industries & Molecules We Support<\/h2>\n
We support a wide range of drug modalities and development stages, with stability programs tailored to the unique requirements of each product type and regulatory pathway.<\/p>\n
\n- Biologics & Biosimilars<\/li>\n
- Small Molecule APIs & Drug Products<\/li>\n
- Injectables, Orals, Topicals<\/li>\n
- Preclinical to Commercial Stage Products<\/li>\n
- Support during Investigational New Drug (IND) and New Drug Application (NDA) submissions<\/li>\n<\/ul>\n<\/div>
Let\u2019s Design a Stability Program That Works for You<\/h2>\n
Our experts are ready to create a custom protocol for stability testing of pharmaceuticals that aligns with your product\u2019s characteristics, development stage, and regulatory objectives.<\/p>\n<\/div>