Stability Study Services – Canada
Stability Protocol Preparation (Health Canada Aligned)
Long-term, accelerated & intermediate stability study design
ICH climatic zone–appropriate storage conditions
Batch selection, pull points & acceptance criteria
Finished dosage forms, APIs, OTCs, NHPs, cosmetics & nutraceuticals
Compliance with ICH Q1A–Q1F, Food and Drug Regulations, and Health Canada guidance
Stability Report Preparation
Health Canada–ready stability study reports
Clear tabulation and scientific evaluation of stability data
Shelf-life / expiry dating & retest period justification
OOS / OOT assessment and conclusions
Suitable for NDS, ANDS, SNDS, DMF, DIN, NHP submissions & annual reports
Graphical Trend Analysis
Assay, impurities, dissolution, degradation products & physical attributes
Statistical trend analysis & early OOT detection
Batch-to-batch and strength-wise comparison
Inspection-friendly graphs with concise scientific interpretation
Health Canada Regulatory Query Handling
Stability-related Health Canada deficiency & clarification responses
Shelf-life extension & re-evaluation support
Support during review cycles & GMP inspections
Products Supported
Finished dosage forms (IR/MR tablets, capsules, liquids, injectables, topicals, inhalations)
APIs & drug substances (DMFs)
OTC products
Natural Health Products (NHPs)
Cosmetics & nutraceuticals
Why StabilityPro for Canada?
Experience with Health Canada NDS, ANDS, DMF & NHP submissions
Strong alignment with ICH Q1 & Canadian regulatory requirements
Inspection-ready, authority-acceptable documentation
Reduced regulatory observations and faster approvals
End-to-end stability documentation lifecycle support