Stability Study Services – Ahmedabad

Stability Protocol Preparation (India-Compliant)

• Long-term, accelerated & intermediate stability study design

• ICH climatic zone–appropriate conditions (as per market intent)

• Batch selection, pull points & acceptance criteria

• Finished dosage forms, APIs, cosmetics & nutraceuticals

• Compliance with ICH Q1A–Q1F, Schedule M & CDSCO guidance

Stability Report Preparation

• CDSCO & State FDA–ready stability study reports

• Scientific evaluation of stability data

• Shelf-life / retest period justification

• OOS / OOT investigation summaries

• Suitable for new drug applications, renewals, variations & exports

Graphical Trend Analysis

• Assay, impurities, dissolution & physical parameter trending

• Statistical evaluation & early OOT detection

• Batch-to-batch & strength-wise comparison

• Regulator- and auditor-friendly graphs

Regulatory Query & Audit Support

• Response to CDSCO / Gujarat FDCA stability queries

• Shelf-life extension & justification support

• Assistance during WHO-GMP, US FDA, EU GMP inspections

Products Supported

• Finished dosage forms (tablets, capsules, liquids, injectables, topicals)

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals & herbal products

Why StabilityPro in Ahmedabad?

• Strong experience with Ahmedabad & Gujarat-based manufacturers

• CDSCO, WHO & ICH-aligned stability documentation

• Inspection-ready, authority-acceptable outputs

• Reduced regulatory observations & faster approvals

• End-to-end stability documentation lifecycle support