Stability Study Services – Hong Kong

Stability Protocol Preparation (DOH Aligned)

• Long-term & accelerated stability study design

• ICH climatic zone–appropriate storage conditions

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1 series and DOH requirements

Stability Report Preparation

• DOH-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 & variations

Graphical Trend Analysis

• Assay, impurities, dissolution & physical attribute trending

• Early identification of OOT trends

• Batch-to-batch comparison

• Regulator-friendly graphs with concise interpretations

DOH Regulatory Query Handling

• Stability-related deficiency response drafting

• Shelf-life revision & scientific 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 Hong Kong?

• Experience with Hong Kong DOH submissions

• ICH & WHO-aligned stability documentation

• Inspection-ready, authority-acceptable outputs

• Reduced regulatory queries and faster approvals

• End-to-end stability documentation lifecycle support