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. 

 

 

 

Our services

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.

 

Pricing and reimbursement (Drugs and Medical devices)

Our experienced consultants can provide support and strategic advice prior to the launch of your products in France.

Our services include:

  • Strategic consulting and management of projects related to pricing and reimbursement of pharmaceutical products and medical devices in France
  • Writing of reimbursement and economic dossiers for application to the HAS (the French Health technology assessment agency) as well as through pricing negotiations with the CEPS (the French Economic Committee for Healthcare Products)
  • Writing of Core value dossier for EU countries including France
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Our experts

Associated services

Role of Responsible Pharmacists in France

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).

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Worldwide

BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements

Associated services

Launch Activities

Clients rely on BlueReg’s regulatory intelligence as well as the experience and expertise of our consultants and partner network for the success of their projects. BlueReg can provide an end-to-end project plan to guide you through the regulatory preparation of the commercial product launch.

Associated services

Drug Registration and Regulatory Roadmap

BlueReg can be your preferred partner to support the registration of your medicinal product in Europe, in the US or in other worldwide countries. Our team of experts can also facilitate and guide clients through the process of formulating the roadmap, provide critical review of one or more elements of the roadmap, or provide hands on operational support through authoring some or all the components.

Associated services

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.

Associated services

Exploitant Services

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).

Associated services

Export Countries

BlueReg is your strategic partner to meet your goals for all medicinal product registrations worldwide. BlueReg provides comprehensive regulatory affairs services, in global regulations and intelligence, across all regions of the world

Associated services

Promotional Material Review

BlueReg is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance.

Associated services

Preparation, writing and redaction of clinical study reports

BlueReg can support you with a highly experienced team of professsionals in preparing and writing of your clinical study reports, supporting the redaction proposal and document package for submission to the EMA to comply with EMA policy 0070.

Associated services

Pharmacovigilance

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.

Associated services

Safety reports

Bluereg has extensive experience in writing safety documents and can support you with assessing a product’s risk benefit profile for your product. 

Associated services

Quality System and Audit

BlueReg experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations in France.

 

Associated services

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).

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