Stability Study Services – Bhutan

Stability Protocol Preparation (DRA Aligned)

• Long-term & accelerated stability study design

• Climatic zone–appropriate conditions (as per WHO/DRA expectations)

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• ICH Q1 series & WHO TRS compliance

Stability Report Preparation

• DRA-ready stability study reports

• Clear presentation of stability data

• Scientific evaluation & conclusions

• Shelf-life / retest period justification

• Suitable for registration, renewal & variations

Graphical Trend Analysis

• Assay, impurities, dissolution & physical attribute trending

• Early identification of OOT trends

• Batch-to-batch comparison

• Regulator-friendly graphs and interpretations

DRA Regulatory Query Handling

• Stability-related deficiency response support

• Shelf-life revision & justification

• Support during registration and 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 Bhutan?

• Experience with Bhutan DRA submissions

• WHO & ICH-aligned stability documentation

• Inspection-ready, authority-acceptable reports

• Reduced regulatory queries and faster approvals

• End-to-end stability documentation lifecycle support