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.
From pricing and reimbursement strategy to submission to the Authorities, we provide flexible solutions to meet your company’s needs.
Strategic consultancy for pricing and reimbursement
- Recommendation on reimbursement and pricing strategy
- Expertise through the complete reimbursement process: new drugs and extension of indications or reassessment
Pricing and reimbursement application support
- Writing of reimbursement dossiers for the Haute Autorité de Santé / French National Authority for, Health (HAS) (new registration, renewal, change of registration conditions and reassessment)
- Writing of pricing dossiers for the Comité Economique des Produits de Santé / French Economic Committee for Healthcare Products (CEPS): new registration and price increase
- Compilation and submission of the dossiers
- Interaction with authorities at every stage of the reimbursement process
Our latest engagements
- Strategic consultancy for pricing and reimbursement for a company launching an innovative medicinal product in the French hospital market
- Writing of pricing and reimbursement files for a new medical device
- Preparation of a meeting with the French National Authority for Health (HAS)
Why work with BlueReg?
The team can provide full support for all aspects of the pricing and reimbursement process from registration to product maintenance activities providing strategic consultancy and/or hands-on operational support.
BlueReg provide expertise in registration strategy in the US or in Europe, provide manpower to produce high quality registration dossiers using our multidisciplinary team of regulatory affairs, scientific writing, and publishing, and manage submission process through to a satisfactory conclusion
Life Cycle Management
The dedicated BlueReg lifecycle management product supply team are experts in navigating post approval activities and supporting client partners to successfully manage all post approval activities.
Quality System and Audit
BlueReg experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations in France.
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.
Promotional materials review (France)
Searching to Outsource Post Authorisation activities?
BlueReg can help with all post-authorization activities for your medicinal products worldwide.
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.
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