PHARMACEUTICALS AND REGULATORY AFFAIRS

We have developed specific expertise in the pharma sector and are able to provide a specialised service for the management of authentication and legalisation obligations regarding the documentation of clients operating in the pharmaceutical, medical device and supplements sectors.
During the annual renewal of licences and certification in general, we work side-by-side with the regulatory affairs functions of a number of sector companies to arrange and update the authentication of documents for authorisation and the placement of products on foreign markets.
We take care of authenticating, translating and legalising all documents issued by the AIFA [Italian Medicines Agency], Ministry of Health and other specific certification bodies (e.g. Local Health Authorities, Notified Bodies), in particular:

• Manufacturing Authorisations
• Acknowledgement deeds
• GMP certificates
• CPP – Certificates of Pharmaceutical Products
• Certificates of Free Sale
• Health Certificates
• ISO Certificates
• CE Certificates