Quality > Regulatory
Regulatory affairs is a corporate function with supervision over the various sites aimed at guaranteeing the same level of regulatory compliance. It ensures the acquiring of authorizations according to national regulations and, strong in the knowledge of international regulations, supports the client with its registrations. In generic spheres, ensures the depositing of DMF at FDA, EDQM and WW.
F.I.S. is authorized by AIFA in the production of more than 100 APIs at its 3 Italian sites.
It has recorded more than 55 DMF with US FDA, over 30 CEP with EDQM and maintains more than 20 DMF deposited with the PMDA JP.
The MM site is inspected periodically by various regulatory authorities such as AIFA, US FDA (since 1964), Ministry of Health Veterinary Department, as well a KFDA, PMDA Japan, ANVISA, Russian Federation. In addition, the Lonigo site and that of Termoli are inspected periodically by AIFA, FDA, KFDA and PMDA Japan (Lonigo). This multiplicity of positive evaluations makes the level of compliance ever more reliable and robust.
Current production authorization
- F.I.S. is authorized by AIFAto produce bulk pharmaceutical intermediates by Spray Drying technology in Montecchio Site as result of the successful inspection of March 2016
- F.I.S. is authorized by AIFA / Italian Ministry of Health to produce more than 100 APIs belonging to Anticancer, Steroids, Psychotropic, Non beta-lactam antibiotics, Veterinary, in dedicated or segregated suites other than categories produced in multipurpose-plants.
- More than 55 US FDA DMF
- More than 30 CEP-EDQM
- More than 20 JP DMF