Quality Assurance

Quality Assurance

Quality Assurance acts as an independent and autonomous function guaranteeing that all manufacturing departments work according to company’s standard operating procedures and in compliance with current Good Manufacturing Practices.

The company has more than:

70 EU DMFs (15CEP)

30 US DMFs

10 JP DMFs

Both Erregierre's sites are FDA approved:

- San Paolo d'Argon manufacturing site has been again inspected successufully by the US FDA in July 2019 with no 483 forms issuance.

- Sovere site has been approved by FDA on the basis of AIFA Inspectiion held in June 2018 (Mutual Recognition Approved)