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.
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.
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.
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.
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.
The integrated approach delivered full compliance and a rapid path to market across Europe and the UK.
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成功案例Support your entry into the European pharmaceutical market with expert regulatory guidance, ensuring compliance and access to essential medicines for patients. Contact us today for assistance.
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