ACPS-Network is a science-based CRO that provides customised services for the early clinical development of new drug substances and drug products
ACPS-Network is a science-based CRO that provides customised services for the early clinical development of new drug substances and drug products
EMA/15975/2016 (“Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of …
Authorization of multi-origin (generic) drugs is based on the argument of equivalence vs. the originator. To this purpose. clinical therapeutic equivalence studies …
Pharmacovigilance (PV) of authorised medicinal products is regulated by a series of regulations, directives, laws and guidelines. These rulings do not relate …