Stability Study Services – Bangladesh

Stability Protocol Preparation (DGDA Aligned)

• Long-term & accelerated stability study design

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

• Batch selection, pull points & acceptance criteria

• API, finished dosage forms, cosmetics & nutraceuticals

• ICH Q1, WHO TRS, DGDA guideline compliance

Stability Report Preparation

• DGDA-ready stability study reports

• Tabulated data with scientific evaluation

• Shelf-life / retest period justification

• OOS / OOT assessment and conclusions

• Suitable for registration, renewal & variations

Graphical Trend Analysis

• Assay, impurities, dissolution & physical parameter trending

• Early OOT identification

• Batch-to-batch comparison

• Authority-friendly graphs with interpretations

DGDA Regulatory Query Handling

• Stability-related deficiency responses

• Shelf-life justification support

• Post-approval change & renewal support

Products Supported

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

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals & herbal products

Why StabilityPro for Bangladesh?

• Proven DGDA submission experience

• WHO & ICH-aligned documentation

• Inspection-ready, authority-acceptable outputs

• Reduced regulatory observations

• End-to-end stability documentation lifecycle support