The registration process of medicinal products can be carried out by applying different procedures required by current regulations:

• National procedure
• Mutual recognition procedure (MRP)
• Decentralised procedure (DCP)
• Centralised procedure (CP)
• The choice of one procedure rather than another depends on the interests and purposes of the company, as well as on the type of product.

Di Renzo Regulatory Affairs has set up a unit consisting of several technical experts (a doctor, chemists, biologists, pharmacists and other personnel with degrees in chemistry and pharmaceutical technology), as well as administrative personnel, including mother tongue English, German and American employees.

The languages normally spoken in our company, apart from Italian, are English, German, French, Spanish and Chinese.

The services that Di Renzo Regulatory Affairs is able to offer are as follows:

• Consultancy on national and international legislation
• Preliminary evaluation of the documentation prepared by the company
• Consultancy and preparation of AIC (MA) applications for national, mutual recognition, decentralised and centralised procedures
• Consultancy and preparation of variations and AIC (MA) renewals
• Consultancy on applications requiring authorisation to produce raw materials and final products
• Development and translation of SPCs, labels and PILs in accordance with current guidelines
• Sworn translation of leaflets and labels in German and insertion into the Unifarm database (bilinguism)
• Consultancy and development of dossiers
• Price negotiation at the AIFA
• Request for certificates of free sale
• Working relationships with consulates for visa releases
• Due diligence
• Technical support during meetings with AIFA, Ministry of Health, ISS or other Regulatory authorities
• Design and preparation of mock ups of outer and immediate packages
• Development of scientific texts, design and graphic layout of brochures, leaflets and final printing
• Transformation of dossiers into eCTD
• Refresher training company course that may be carried out at our offices in Rome, Milan or at the premises of the company itself
• Legal consultancy
• Collaboration in SOP development

Furthermore, Di Renzo Regulatory Affairs has singled out some operative unit in its own structure in order to manage some activities that are becoming increasingly more outsourced.