Stability Study Services – Côte d’Ivoire

  • Stability Protocol Preparation (DPML Aligned)

    • Long-term & accelerated stability study design

    • Climatic Zone IVb conditions (30°C / 75% RH)

    • Batch selection, pull points & acceptance criteria

    • Finished dosage forms, APIs, cosmetics & nutraceuticals

    • Compliance with ICH Q1 series, WHO TRS & DPML guidance

    Stability Report Preparation

    • DPML-ready stability study reports

    • Clear tabulation and scientific evaluation of stability data

    • Shelf-life / retest period justification

    • OOS / OOT assessment and conclusions

    • Suitable for new registration, renewal & post-approval variations

    Graphical Trend Analysis

    • Assay, impurities, dissolution & physical attribute trending

    • Early identification of OOT trends

    • Batch-to-batch comparison

    • Authority-friendly graphs with concise interpretations

    DPML Regulatory Query Handling

    • Stability-related deficiency response drafting

    • Shelf-life revision & scientific justification

    • Support during DPML queries, renewals & post-approval changes

    Products Supported

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

    • APIs & intermediates

    • Cosmetics & personal care products

    • Nutraceuticals & herbal products

    Why StabilityPro for Côte d’Ivoire?

    • Experience with Côte d’Ivoire DPML submissions

    • ICH & WHO-aligned stability documentation

    • Inspection-ready, authority-acceptable outputs

    • Reduced regulatory observations and faster approvals

    • End-to-end stability documentation lifecycle support