The Community Code implemented in Italy with Legislative Decree N ° 219/2006, brings together, in a single act, all the provisions in force regarding the authorization for placing on the market, production, labeling , the classification, distribution and advertising of medicinal products for human use. - Bio Chem assists companies in the sector by processing the technical documentation, including SMF, VMP, CTD, POS, IQ, OQ, PQ and everything related to safety, creating specific Quality Management Systems and following the entire bureaucratic process at the Departments of AIFA and the Ministry of Health responsible for issuing specific authorizations. - Accurate pre-inspection audits, cGxP-GAMP-FDA, feasibility studies and specific training activities are performed. - Assistance on parallel import of drugs.