Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2026August14Healthcare Quality by Design (QbD)-Based Regulatory Dossier Preparation of Imiglucerase: A Review       English0106Harshada R. KhadeEnglish Shilpa PiseEnglishhttps://doi.org/10.31782/IJCRR.2026.181501 The concept of Quality by Design (QbD) enables the incorporation of scientific knowledge and risk management during the development of drugs. Imiglucerase is a recombinant biological enzyme that serves in the treatment of Type 1 Gaucher disease and thus calls for a thorough analysis regarding quality. This paper provides an analysis of the use of QbD in preparing the regu latory dossier of this product. This involves an overview of several aspects including the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), risk assessment and control strategy of Imiglucerase development. The relevance of the Common Technical Document (CTD) and electronic Com mon Technical Document (eCTD) in compiling quality, nonclinical and clinical information about the drug will also be addressed in the paper. EnglishQuality by Design (QbD), Imiglucerase, Regulatory Affairs, Regulatory Dossier, Common Technical Document (CTD), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs), Quality Risk Management (QRM), Biopharmaceuticals.http://ijcrr.com/abstract.php?article_id=4915http://ijcrr.com/article_html.php?did=4915 1. International Council for Harmonisation. ICH Q8(R2): Pharma ceutical Development [Internet]. Geneva: ICH; 2009 [cited 2026 Jun 28]. Available from: https://database.ich.org/sites/default/ files/Q8_R2_Guideline.pdf 2. U.S. Food and Drug Administration. Pharmaceutical Quality Resources [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; [cited 2026 Jul 01]. 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