Stability Study Services – Ukraine

Stability Protocol Preparation (MoH / SEC Aligned)

• Long-term, accelerated & intermediate stability study design

• EU climatic zone–appropriate storage conditions

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1 series, EU GMP & MoH/SEC guidance

Stability Report Preparation

• MoH/SEC-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

• Authority-friendly graphs with concise interpretations

MoH / SEC Regulatory Query Handling

• Stability-related deficiency response drafting

• Shelf-life revision & scientific justification

• Support during MoH/SEC queries, renewals & lifecycle changes

Products Supported

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

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals & herbal products

Why StabilityPro for Ukraine?

• Experience with Ukraine MoH / State Expert Center submissions

• EU, ICH & WHO-aligned stability documentation

• Inspection-ready, authority-acceptable outputs

• Reduced regulatory observations and faster approvals

• End-to-end stability documentation lifecycle support