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Consigli per scrivere SOP

How to draft a SOP

One of the essential elements to manage a risk of non conformity with the regulation inside a company are corporate...

Revisione linguistica

Translation and control of product information during European procedures

The long process leading to the availability of a medicinal product on the market includes a whole set of steps...

Pubblicità Dispositivi medici

Advertising. Medical devices and IVDs

Does your company manufacture or is it responsible for the marketing of medical devices or IVDs and do they wish...

Autorizzare i Novel Food

What is a novel food and how to market it

Consumers’ food choices tend to vary in time and, especially in recent years, new types of foods have arrived on...

Foglio Illustrativo

PIL, a clear and readable source for information to patients

After doctors and pharmacists, the patient information leaflet is the main source of information on medicinal products available to consumers. However, in...

Bilinguismo a Bolzano

Bilingualism, how the rules on drugs work for the province of Bolzano

Article 80 of Legislative Decree no. 219 of 24 April 2006 – i.e. the Italian implementation of Directive 2001/83/EC (as...

Stampa etichette alimentari

Label manufacturing for the food sector

Labels can be considered as the business cards of products. Any kind of product is actually introduced by its label,...

Cannabidiolo come alimento

Cannabidiol as novel food? EFSA say no for now

A panel of scientific experts of the European Food Safety Authority (EFSA) has put on hold the evaluation of the...

Rete nazionale di Farmacovigilanza

National Pharmacovigilance Network, everything changes as 20 June

As of 9 June, we are in full transition phase while waiting for the total effectiveness of the new National...

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