Our services

Regulatory Affairs 
and Pharmacovigilance Services

• Registration of pharmaceutical products through National, Mutual Recognition and Decentralised procedures
• Maintenance of the Marketing Authorisations through variations and renewals
• Preparation and submission of Pricing and Reimbursement applications
• Effective deals with the authorities and intensive follow-up in every submission, in order to ensure timely conclusion of the national phase of the procedures
• High quality translations of the Summaries of Product Characteristics, Labeling and Patient Leaflet to the local language
• Consultancy services concerning the local regulatory provisions and requirements.
• Training in Regulatory Affairs
• Set up and implementation of Pharmacovigilance System
• Collection, Assessment and Reporting of Adverse Events (AEs) originating from clinical trials or other organised data collection systems, spontaneous reports or literature.
• Local Literature review