Authorisations and certifications
Every batch ends up in patients' veins: quality is not a department, it is the way we work. Recognised by independent auditors as an Italian centre of excellence.
GMP
Good Manufacturing Practice for human and veterinary medicines, including Investigational Medicinal Products (IMP). GMP Compliance AIFA · GMP Ministry of Health.
FDA
Approved facility: we can manufacture for the United States market.
CE
Authorisation to manufacture medical devices.
ISO 9001:2015
Quality management system.
ISO 13485:2021
Quality management system for medical devices.
UNI/PdR 125:2022
Gender Equality Management System, certified by ICIM S.p.A.
Read the Policy →
Batch release and traceability
Every batch is released on the basis of the chemical and microbiological testing required by GMP, with full traceability from raw material to finished product — an essential requirement for anyone producing solutions intended for parenteral use.