GMP
Ticinum Lab Pharma Research Center is
certified by the Italian Medicines Agency (AIFA) as a
GMP manufacturing site authorized to perform quality
control testing (on Medicine Products and Investigational
Medicinal Products (IMP) according to Directive 2001/83/EC
(GMP Certificate
n°. IT/91-1/H/2010). It is also certified for veterinary
GMP quality control (Certificate n°. NBF/31/2017/V).
Ticinum Lab Pharma Research Center is registered
with the FDA as a test facility for the analysis
of pharmaceutical products (registration number 3005987780)
and has been successfully inspected by FDA since 2004.
GLP/GCP
Ticinum Lab Pharma Research Center
is certified by the Italian Medicines Agency as a
non-clinical research center to perform chemical
and physical tests (genotoxic impurities,
pharmaceutical ingredients, laboratory-scale synthesis)
according to Italian Legislative Decree DL120/92 and
European Directives 1999/11/ED and 1999/12/EC.
It is also authorized by AIFA to participate in
Good Clinical Practice (GCP) studies as an analytical laboratory.
CONTROLLED DRUGS
Ticinum Lab Pharma Reseach Centre is
authorized by Italian Health Authorities to manage
controlled drugs.
