White Papers
Navigating the new European HTA Landscape.
A practical guide for biopharma companies preparing for their first EMA interaction. Learn 5 critical steps to reduce delays and align with EU regulatory expectations.
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Discover a collection of resources tailored for biopharma companies looking to enter the European market.
White Papers
The Real Dynamics of EU Orphan Incentives
Beyond the regulatory promise: uncover the silent deadlines, timing traps and sequencing logic that determine your real EU orphan exclusivity value.
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Case Studies
Commercial launch of a first medicinal product in Europe
Case study on launching a first medicinal product in Europe, covering EU and national requirements, serialization, risk minimization measures, and fast, coordinated market entry.
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Case Studies
Managing the global geographical rollout of a medicinal product
Case study on managing the global rollout of a medicinal product after EU approval, from strategy and dossier harmonisation to coordinated Health Authority responses and accelerated worldwide registrations.
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Case Studies
Navigating ISO 13485 and MDR 2017/745 for Medical Devices in Europe
See how AzurBio helps medical device manufacturers achieve ISO 13485 certification and MDR 2017/745 compliance for CE marking and faster EU market access.
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Case Studies
AzurBio Solutions for MDR Certification of Substance-Based Medical Devices
Learn how AzurBio helps manufacturers achieve MDR certification for substance-based medical devices, from documentation gaps to Notified Body expectations.
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Case Studies
Case Study: Navigating a French MA for Homeopathic Medicinal Products in France
Discover how AzurBio secured a French MA for a homeopathic medicinal product with indication, strategy, dossier tips, and key regulatory insights.
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Expert Q&As
Why does the MAH need a Pharmacien Responsable when operating in France?
Why does the MAH need a Pharmacien Responsable when operating in France?
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Expert Q&A
What is the “Exploitant” status and why is it essential for pharmaceutical companies entering the French Market?
What is the “Exploitant” status and why is it essential for pharmaceutical companies entering the French Market? What's Inside the Q&A: Access Senior-Level Know-How Learn from experts who have shaped…
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Expert Q&As
Launching in EU – Q&A 10
How can we leverage early access programs and real-world evidence (RWE) to support our European launch?
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