Stability Study Services – United States

tability Protocol Preparation (US FDA 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, cosmetics & nutraceuticals

• Compliance with 21 CFR, ICH Q1A–Q1F, and FDA guidance

Stability Report Preparation

• US FDA–ready stability study reports

• Clear tabulation and scientific evaluation of stability data

• Shelf-life / expiry dating & retest period justification

• OOS / OOT assessment, trend evaluation & conclusions

• Suitable for IND, NDA, ANDA, DMF, supplements & 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

• FDA inspection–friendly graphs with scientific interpretation

US FDA Regulatory Query Handling

• Stability-related FDA deficiency & information request responses

• Shelf-life extension & re-evaluation support

• Support during FDA review cycles & inspections

Products Supported

• Finished dosage forms (IR/MR tablets, capsules, liquids, injectables, topicals, inhalations)

• APIs & drug substances (DMFs)

• OTC products

• Cosmetics & nutraceuticals

Why StabilityPro for the United States?

• Experience with US FDA IND, NDA, ANDA & DMF submissions

• Strong alignment with ICH Q1 & 21 CFR requirements

• Inspection-ready, authority-acceptable documentation

• Reduced FDA observations and faster approvals

• End-to-end stability documentation lifecycle support