Stability Study Services – Russia

tability Protocol Preparation (MoH / EAEU Aligned)

• Long-term, accelerated & intermediate stability study design

• Climatic zone–appropriate storage conditions (cold / temperate climate considerations)

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with EAEU Rules, ICH Q1 series & MoH guidance

Stability Report Preparation

• MoH / Roszdravnadzor-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

Regulatory Query Handling (Russia)

• Stability-related deficiency response drafting

• Shelf-life revision & scientific justification

• Support during MoH / Roszdravnadzor queries

• Assistance for EAEU lifecycle management submissions

Products Supported

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

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals & herbal products

Why StabilityPro for Russia?

• Experience with Russia & EAEU submissions

• ICH, WHO & EAEU-aligned stability documentation

• Inspection-ready, authority-acceptable outputs

• Reduced regulatory observations and faster approvals

• End-to-end stability documentation lifecycle support