CDMO

Approved. Recognised. Trusted.

At Eirgen we understand the importance of maintaining the highest standards of quality throughout each phase in our development, manufacturing, and packaging processes. To do so, we meet the most stringent quality standards as laid out by relevant authorities within the global pharmaceutical industry. 

Our commitment to ensuring the safety and efficacy of our high containment medicines has seen Eirgen apply best-in-class systems and maintain rigorous quality and accountability controls. As a result of meeting and exceeding industry quality standards, Eirgen is now approved by the following regulatory authorities:

 - Ireland’s Health Products Regulatory Authority (HPRA) 

 - European Medicines Agency (EMA) 

 - The U.S. Food and Drug Administration (FDA) 

 - Japan’s Pharmaceuticals and Medical Devices Agency (PDMA)

Eurpean Medicines Agency
HPRA
FDA
PMDA
Eirgen Pharma

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