Hovione has filings with every world health authority that has a DMF system for APIs including FDA EDQM PMDA,MHRA, HPRA, Infarmed among others.

The Regulatory group works closely with R&D, Manufacturing, Quality Control  and Quality Assurance areas to coordinate work requirements from a regulator submission’s point of view, to ensure compliance with the legislation and guidelines in force.

All Site Managers have a direct link to the Regulatory group in order to assure all DMFs are reflected in the plant’s operation.

Also in Quality and Compliance

Health, Safety, Environment and Energy (HSEEn)

Zero accidents is our main goal



Quality is more than a set of rules; it is a state of mind.