Stability Study Services – Cambodia

Stability Protocol Preparation (MOH/DDF Aligned)

• Long-term & accelerated stability study design

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

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• ICH Q1 series & WHO TRS compliance

Stability Report Preparation

• MOH/DDF-ready stability study reports

• Clear tabulation and 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 parameter trending

• Early identification of OOT trends

• Batch-to-batch comparison

• Regulator-friendly graphs with clear interpretations

MOH 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, syrups, suspensions, injections, topicals)

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals & herbal products

Why StabilityPro for Cambodia?

• Experience with Cambodia MOH/DDF submissions

• WHO & ICH-aligned stability documentation

• Inspection-ready, authority-acceptable outputs

• Reduced regulatory observations and faster approvals

• End-to-end stability documentation lifecycle support