Stability Study Services – Italy
Stability Protocol Preparation (EU / AIFA Aligned)
Long-term, accelerated & intermediate stability study design
ICH climatic zone–appropriate storage conditions (EU Zone II)
Batch selection, pull points & acceptance criteria
Finished dosage forms, APIs, cosmetics & nutraceuticals
Compliance with ICH Q1A–Q1F, EU GMP, EMA & AIFA guidance
Stability Report Preparation
AIFA / EMA–ready stability study reports
Scientific evaluation and interpretation of stability data
Shelf-life / expiry dating & retest period justification
OOS / OOT assessment and conclusions
Suitable for MAA, renewals, variations & MRP/DCP submissions
Graphical Trend Analysis
Assay, impurities, dissolution & critical quality attribute trending
Statistical analysis with early OOT detection
Batch-to-batch & strength-wise comparison
Authority-friendly graphical presentations
EU / AIFA Regulatory Query Handling
Response to AIFA / EMA stability-related queries and deficiencies
Shelf-life extension & scientific justification support
Assistance during EU GMP inspections and review cycles
Products Supported
Finished dosage forms (oral solids, liquids, injectables, topicals)
APIs & intermediates
Cosmetics & personal care products
Nutraceuticals & food supplements
Why StabilityPro for Italy?
Experience with Italy AIFA & EU EMA submissions
ICH-, WHO- & EU-aligned stability documentation
Authority-acceptable, inspection-ready deliverables
Reduced regulatory queries and faster approvals
End-to-end stability documentation lifecycle support