Stability Study Services – Taiwan

Stability Protocol Preparation (TFDA Aligned)

• Long-term, accelerated & intermediate stability study design

• ICH climatic zone–appropriate storage conditions
  (Primarily Zone IVb – 30°C / 75% RH, unless otherwise justified)

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1A–Q1F, TFDA technical guidelines & CTD requirements

Stability Report Preparation

• TFDA-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 changes

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

TFDA Regulatory Query Handling

• Response to TFDA 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 & health supplements

Why StabilityPro for Taiwan?

• Experience with TFDA submissions

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

• Authority-acceptable, inspection-ready deliverables

• Reduced regulatory queries and faster approvals

• End-to-end stability documentation lifecycle support