Stability Study Services – Brazil

Stability Protocol Preparation (ANVISA Aligned)

• Long-term, accelerated & intermediate stability study design

• ICH climatic zone–appropriate storage conditions
  (Primarily Zone IVb – hot & humid: 30°C / 75% RH, as applicable)

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1A–Q1F, ANVISA RDC guidance & Brazilian Pharmacopoeia considerations

Stability Report Preparation

• ANVISA-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 new registrations, generics, renewals & post-approval variations

Graphical Trend Analysis

• Assay, impurities, dissolution & critical quality attribute trending

• Statistical analysis with early OOT detection

• Batch-to-batch & strength-wise comparison

• Regulator-friendly graphical presentations

ANVISA Regulatory Query Handling

• Response to ANVISA stability-related queries and deficiencies

• Shelf-life extension & scientific justification support

• Assistance during technical review cycles and GMP inspections

Products Supported

• Finished dosage forms (oral solids, liquids, injectables, topicals)

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals & food supplements

Why StabilityPro for Brazil?

• Experience with Brazil ANVISA submissions

• ICH-, WHO- & LATAM-aligned stability documentation

• Authority-acceptable, inspection-ready deliverables

• Reduced regulatory queries & faster approvals

• End-to-end stability documentation lifecycle support