Stability Study Services – Myanmar

Stability Protocol Preparation (FDA Myanmar Aligned)

• Long-term & accelerated stability study design

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

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1 series, WHO TRS & FDA Myanmar guidance

Stability Report Preparation

• FDA Myanmar–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

• Regulator-friendly graphs with concise interpretations

FDA Myanmar Regulatory Query Handling

• Stability-related deficiency response drafting

• Shelf-life revision & scientific justification

• Support during FDA Myanmar queries, renewals & post-approval changes

Products Supported

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

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals & traditional/herbal products

Why StabilityPro for Myanmar?

• Experience with Myanmar 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