Guiding you to regulatory compliance

Many of our customers come to us for guidance on the latest regulatory requirements and quality standards.

Ardena has extensive knowledge of the European and American regulatory frameworks and guarantees compliance with all applicable guidelines and directives.

At Ardena, we take a dossier-centric approach to drug development. By developing product and dossier in parallel, quality and regulatory compliance can be ensured from the start of a project.

With drug developers under increasing time and cost pressures, this helps to streamline the drug’s progress to clinic and eventually commercial production.