Stability Study Services – India

Stability Protocol Preparation (CDSCO Aligned)

• Long-term, accelerated & intermediate stability study design

• Climatic Zone IVb conditions (30°C / 75% RH)

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1 series, Schedule M & CDSCO guidance

Stability Report Preparation

• CDSCO / State FDA-ready stability study reports

• Clear tabulation and scientific evaluation of stability data

• Shelf-life / retest period justification

• OOS / OOT assessment and conclusions

• Suitable for new drug approval, registration, renewal & variations

Graphical Trend Analysis

• Assay, impurities, dissolution & physical parameter trending

• Early identification of OOT trends

• Batch-to-batch comparison

• Authority-friendly graphs with concise interpretations

Regulatory Query Handling (India)

• Stability-related deficiency response drafting

• Shelf-life revision & scientific justification

• Support during CDSCO queries, renewals & post-approval changes

• Inspection readiness support for stability sections

Products Supported

• Finished dosage forms (tablets, capsules, liquids, injectables, topicals, inhalation)

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals, herbal products & food supplements

Why StabilityPro for India?

• Extensive experience with CDSCO & State FDA submissions

• ICH & WHO-aligned stability documentation

• Inspection-ready, authority-acceptable outputs

• Reduced regulatory observations and faster approvals

• End-to-end stability documentation lifecycle support