A dedicated team of highly qualified consultants providing services in France. The team have:
- Significant hands-on industry experience and broad expertise in national Regulatory Affairs, Quality Management, Market Access and Pharmacovigilance.
- Varied and flexible skills, ranging from strategic consulting to operational execution, as well as leading and managing projects.
This team provides expert advice as well as supporting with hands-on operational activities. The team works with many clients, from biotech start-ups to large pharma companies looking for local expertise or specific services for France. The team have a highly successful track record of delivering all projects, from the simple to the complex.
- Review and submission of local promotional materials for pharmaceutical products and medical devices
- Preparation of cohort ATU (early access) applications for an Orphan Drug
- Handling of all local regulatory activities for a portfolio of pharmaceutical products
- Supporting a US client in obtaining an “Exploitant” status from the French National Agency for the Safety of Medicines and Health Products (ANSM) for their newly created affiliate in France. This included providing strategic advice to the client, setting up a specific Quality Management System (QMS) and preparing the “Exploitant” application filed to ANSM.
Promotional Material Review in France
BlueReg peut vous accompagner pour du conseil ou de la gestion opérationnelle afin de garantir la conformité de toutes vos opérations avec les exigences qui s’appliquent en France
The BlueReg team have a highly successful track record of delivering all French market specific services, from the simple to the complex providing expert advice as well as hands-on operational support..
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
Looking for help and support in entering the UK? Our UK based consultants can provide support and advice for all your project requirements in relation to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Looking for help with regulatory activities in the United States? BlueReg can help to navigate the Food and Drug Administration (FDA) regulations and provide support and advice for all your project requirements.
Looking for support in marketing your product in France? PharmaBlue, a BlueReg company, is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted a temporary use authorization (ATU) or a marketing authorisation (MA).
Product Quality Review
BlueReg has an experienced team for Product Quality Review (PQR) writing including CMC, Quality and Regulatory Affairs consultants dedicated to supporting your company through PQR reviews for your medicinal products.
Market Access France
BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices) in France.
BlueReg assists companies to plan and submit any necessary changes to existing marketing authorizations before the end of the Brexit transition period in order to comply with EU law. Please contact us or follow our BlueReg Linkedin page to be kept up to date with the Medicines and Healthcare products Regulatory Agency (MHRA) Brexit guidance as they are issued.
BlueReg will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services.
BlueReg can assist with all your audit requirements and can provide a complete audit preparation package which we can tailor to your needs.
Specific Services for Europe
BlueReg has a dedicated team who cover the whole development process from concept to approval, on centralized or multi-national projects. Our consultants have diverse experience ranging from regulatory strategy to operational execution and full project management support will be provided.
Early Access Programs in France
Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs projects in France .
Pricing and reimbursement (Drugs and Medical devices)
BlueReg consultants can provide pricing and reimbursement insight and support you prior to the launch of your products in France. BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices).
The French system for preventing and managing shortages
The French regulation on the prevention and management of stock shortages of medicinal products is...
New Appointment to our Leadership Team !
BlueReg Group is delighted to announce the appointment of Dominique Patrone as General Manager of PharmaBlue....