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GMP validity extension, Distant Assessment and on site audits: AIFA inspection unit slowly back to normal

Audits at medicines and APIs manufacturing sites are certainly one of the pharmaceutical manufacturing activities that were more affected by...

Monacolins from Fermented Red Rice in Food Products, Updates

Last 5th of October 2021, the European Commission gathered in order to discuss the draft Regulation on the use of monacolins...

Eudamed: new modules for medical device and notified body registration online

The progressive implementation of the web-based portal Eudamed – the European databank of medical devices provided for by Regulations (EU) 2017/745 and 2017/746 (MDR...

E-commerce of foods and food supplements, a growing market

Online retail sale is an essential strategy for most small- and medium-sized enterprises operating in the food sector, not only to widen...

Parabens, use and effects

In the latest decades, people has been devoting more attention to taking care of their body and appearance, and this...

The import of medical devices in Italy

The concept of “import” is not precisely straightforward, even if it is considered trivial. Initially “import” meant the transit of...

Clinical trials information system (ctis)

The single European Clinical Trials Information System (CTIS) will come into force along with EU Regulation 2014/536 on clinical trials of medicinal products for human use...

Traceability of cosmetics for the safety of companies and consumers

Cosmetic products include a wide range of items (creams, shampoos, body care and hygiene products, but also make-up and sun...

Marketing narcotics: regulations and criticalities

Obtaining the marketing authorisation for narcotics is a delicate procedure, regulated by specific norms whose compliance is carefully monitored by the Italian...