We market our products in Italy and abroad. For this reason, Fidia is periodically inspected by national and international regulatory authorities (AIFA, the Italian Ministry of Health, US FDA, Korean Ministry of Food and Drug Safety [KFDA], ANVISA Brazil, Pharmaceutical Inspectorate of the Ministry of Industry and Trade of the Russian Federation) and Notified Bodies (GMED, ISS, TUV, IMQ, Certiquality, Eurofins Biolab, UKA, UA).
Our Quality Management System
- Complies with European GMP requirements for the production of medicinal products and active pharmaceutical ingredients and is certified according to standards ISO 13485 and ISO 9001.
- Complies with the requirements of 21 CFR Part 211 and 21 CFR Part 820 for the production and marketing of medicinal products and medical devices in the United States.
- Since 2018 the site undergoes auditing in line with the requirements of the Medical Device Single Audit Programme (MDSAP) to be able to produce and market our own medical devices in the USA, Canada, Brazil and Australia.
Quality Assurance
We strive to prevent compliance issues for our products: our aim is to implement and maintain an effective Quality Management System.
Quality Control
We perform analytical controls to guarantee the use of raw materials with the required quality characteristics. We perform analytical tests finished products to ensure the products marketed are safe and effective.
Our plants
In our plants we produce and package medicinal products, active substances and medical devices
Find out more
Find out more
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