Pharmaceutical Company Dedicated platforms to support • Manages local pharmaceutical activities Pharmaceutical activities including regulatory, quality, medical information, pharmacovigilance, batch follow-up… • Regulatory • Promotional Copy Review • Medium / long term partner providing Exploitant services • Quality to clients for fast market access in France for their approved medicines (Orphan or unmet medical need) • Medical Information • Pharmacovigilance French Market specificity : • Distribution - batch follow-up ATU : Early Access to Innovation HTA and contracting with payers integrated PharmaBlue provides the “exploitant” support using approach BlueReg resources to handle required activities • Provision of ad-hoc advice or responding to specific Provides Strategic recommendations for product questions, including strategy and/or positioning of ATU positioning value dossiers to ensure optimal patient projects. access and reimbursement • Supports clients in consulting with KOLs, key payers • Preparation or review of ATU application including the and HTA bodies at national and EU levels protocol for therapeutic use (PUT) • Utilize our EU Network to provide tailored solutions to • Submission of ATU dossiers to ANSM and follow up until every client ATU granted Committed to making sure that medicines reach patients • Pre-launch activities for the management of ATU without unnecessary delay programmes (see description later) • Day-to-day management of ATU programme: Patient French Market specificity : inclusion and follow up, validation of the pharmacist « Exploitant » Pharmaceutique orders, processing and capturing of all necessary data Pharma Blue is certified by ANSM in France as an • Generation and submission of ATU periodic reports “Exploitant” • Support pharmaceutical companies for the marketing A BlueReg Company in France of their medicinal products which have « Pharma Blue benefits from the BlueReg group’s expertise been granted an early access authorization (ATU) or a to ensure a service that meets regulatory requirements and marketing authorization (MA). best practice obligations »