Regulatory Affairs

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 Regulatory Affairs