Stability Study Services – Roorkee

Stability Protocol Preparation (India & Global Aligned)

• Long-term, accelerated & intermediate stability study design

• ICH climatic zone–appropriate conditions based on target markets
  (India, US, EU, UK, ASEAN, GCC, Africa & LATAM)

• 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 & Uttarakhand FDA–ready stability study reports

• Scientific evaluation and interpretation of stability data

• Shelf-life / retest period justification

• OOS / OOT investigation summaries

• Suitable for new registrations, renewals, variations & export dossiers

Graphical Trend Analysis

• Assay, impurities, dissolution & critical quality attribute trending

• Statistical analysis with early OOT detection

• Batch-to-batch & strength-wise comparison

• Regulator- and auditor-friendly graphical outputs

Regulatory Query & Audit Support

• Response to CDSCO / Uttarakhand FDA stability queries

• Shelf-life extension & scientific justification support

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

Products Supported

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

• APIs & intermediates

• Cosmetics & personal care products

• Nutraceuticals & herbal products

Why StabilityPro in Roorkee?

• Experience with Roorkee–Haridwar pharma manufacturers

• CDSCO, WHO & ICH-aligned stability documentation

• Inspection-ready, authority-acceptable deliverables

• Reduced regulatory observations & faster approvals

• End-to-end stability documentation lifecycle support