Stability Study Services – Portugal

Stability Protocol Preparation (EU / INFARMED Aligned)

• Long-term, accelerated & intermediate stability study design

• ICH climatic zone–appropriate storage conditions (EU Zone II; Southern Europe considerations where applicable)

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1A–Q1F, EU GMP, EMA & INFARMED guidance

Stability Report Preparation

• INFARMED / 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 / INFARMED Regulatory Query Handling

• Response to INFARMED / 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 Portugal?

• Experience with Portugal INFARMED & 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