Stability Study Services – Nepal

Stability Protocol Preparation (DDA Aligned)

• Long-term & accelerated stability study design

• Climatic zone–appropriate storage conditions (Zone IVb where applicable)

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1 series, WHO TRS & DDA guidance

Stability Report Preparation

• DDA-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 registration, renewal & post-approval variations

Graphical Trend Analysis

• Assay, impurities, dissolution & physical attribute trending

• Early identification of OOT trends

• Batch-to-batch comparison

• Authority-friendly graphs with concise interpretations

DDA Regulatory Query Handling

• Stability-related deficiency response drafting

• Shelf-life revision & scientific justification

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

Products Supported

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

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals & herbal products

Why StabilityPro for Nepal?

• Experience with Nepal DDA submissions

• ICH & WHO-aligned stability documentation

• Inspection-ready, authority-acceptable outputs

• Reduced regulatory observations and faster approvals

• End-to-end stability documentation lifecycle support