Quality Control

A high level of quality is granted by Steroid’s QC Laboratories which are alsobusy in carrying out and developing new analytical methods specifically developed for its APIs. For some of its APIs Steroid counts also with the Certificate of Suitability issued by the European Directorate for the Quality of Medicines (EDQM). As an European manufacturer Steroid operates in all its activities following the EU GMP (ICHQ7). The compliance is guaranteed by the QA Department and regularly inspected by the Italian Health Authorities AIFA.

Regulatory Affairs

All the APIs manufactured by Steroid are supported by Active Substance Master Files in CTD format and by all the necessary documentation for finished products registrations. In addition, Steroid can also provide “ad hoc” documentation for those Authorities requiring specific studies on APIs.