France Local Regulatory, Quality & Pharmacovigilance Our services • Interaction and meetings with the French Authorities (ANSM) • Regulatory support for clinical trials • Early access programme (ATU): Ad-hoc advice, Preparation of the ATU application, Submission of ATU dossiers to ANSM and follow up until ATU is granted, Day-to-day management of ATU programmes, Generation and submission of ATU periodic reports • Advice and operational support for commercialisation of drugs in France: Pharmacovigilance, Supply chain, Review of promotional materials, Review of packaging materials, Market Access, ComplianceThe team of the interactions with HCP (DMOS), Assistance in the certification of Sales Representatives (Charte de la visite médicale) A team of highly qualified consultants with significant hands-on industry experience • Advice and support for “Exploitant” activities:to obtain and maintainincluding experts in Regulatory Affairs, Quality Exploitant license in France including writing SOPs and product qualitymanagement and Pharmacovigilance. reviews. When work with us? Our clients For any types of projects even the most sensitive and complex. From start-ups to global pharma companies with punctual, repetitive or permanent need Among our latest missions for support. • Review and submission of promotional materials for pharmaceuticalWhy work with us? products and medical devices • Preparation of a cohort ATU (early access) application For an OrphanA “France” dedicated team with significant Drug Regulatory, Quality & Pharmacovigilance experience. • Handling of all local regulatory activities for a portfolio of pharmaceuticalThey can provide expert advice followed by products hands-on operational activities.