AURENA is dedicated to provide quality services that meet the requirements and expectations of regulations and customers.

AURENA is certified in accordance with SS-EN ISO 13485:2003. The operations are also adapted in accordance with cGMP (current Good Manufacturing Practice).

The clean-rooms at AURENA meet Class 6 (EN-ISO 14644-1).
The sterile saline products that AURENA offers are approved and CE-marked in accordance with the EU’s medical technology Directive, MDD, a statutory mark for medical devices in Europe.

AURENA Laboratories is registered by the FDA as a Drug Establishment and has a FDA Labeler Code number.