Case Studies Archives - AzurBio - Accelerating biopharmas expansion to EU

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.

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.

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.

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.