QbD Group
    Case Study

    Landing in Europe: Henlius's EU Market Entry

    Discover how QbD Group helped Henlius, a China-based biopharmaceutical company, achieve full regulatory compliance and launch in the EU within 3 months of Marketing Authorisation grant.

    3 de junio de 20262 min de lectura

    Henlius is a China-based global biopharmaceutical company specialising in innovative monoclonal antibody medicines. To bring their centrally approved products to patients across Europe and the UK, Henlius required a comprehensive partner to cover all regulatory, quality, pharmacovigilance, and supply chain responsibilities under complex EU requirements.

    Desafío

    Henlius's products were registered via the EMA Centralised Procedure, requiring simultaneous compliance across all EU member states. Multiple positions had to be filled: Marketing Authorisation Holder (MAH), Qualified Person (QP), Pharmacovigilance (PV) contact, and Pharmaceutical Agent (PA).

    In addition to fulfilling these regulatory roles, a fully compliant EU supply chain had to be built from the ground up, with serialisation implemented across all relevant markets. The complexity of managing all these requirements simultaneously, under the strict timelines of a centrally authorised product, required a single coordinated partner capable of covering the full scope.

    Enfoque

    An all-in-one solution for EMA Centralised Procedure products

    QbD Group provided an end-to-end regulatory and compliance solution, acting as the single accountable partner across all required roles and services for EU and UK market entry.

    • EU and UK Marketing Authorisation Holder (MAH) services
    • Regulatory Affairs services covering both the EU and UK
    • Serialisation implementation and continuous operational support
    • EU Importer and Qualified Person (QP) services
    • Pharmacovigilance (PV) services

    Throughout the engagement, QbD Group ensured all positions were filled in full compliance with EMA Centralised Procedure requirements, enabling Henlius to focus on commercialisation while QbD Group managed the regulatory infrastructure.

    Resultado

    Henlius's monoclonal antibodies, live across the European market

    The integrated approach delivered full compliance and a rapid path to market across Europe and the UK.

    • Marketing Authorisation approved in EU and UK: all MA, RA, PV, QP, and serialisation requirements met following the Centralised Procedure.
    • First markets launched within 3 months: products successfully launched in initial European markets within 3 months of MA grant.
    • Lifecycle Management ongoing: MAH support and lifecycle management services continue as products expand across Europe.

    QbD Group

    ¿Listo para dar el siguiente paso?

    ¿Listo para acelerar tu proyecto en Life Sciences? Habla con nuestros expertos.

    Contacta con un experto →
    Comparte este artículo

    Sigue leyendo

    Contenido relacionado