Coordination and regulatory support across Europe and the rest of the world
This service is utilised by small start-up companies or companies that have not yet had a product reach the EU or US market. They generally have no in-country regulatory resource. This service may also be of interest to medium sized companies who do not have presence in all countries in the world.
This service can be used during the entire geographical rollout registration process, from geographical rollout through to launch and marketing of the product following approval.
BlueReg can guide you through:
- Any country to country requirements for local regulatory strategy and registrations,
- Promotional copy review and regulatory validation
- Healthcare compliance
- Supply chain and labelling review
- Pricing and reimbursement
- Launch preparation
- Post approval submissions
In addition to our offices in France and the UK, we have a network of partners around the world. All our partners are fully qualified and have significant experience in their technical speciality and market.
With BlueReg, you only need to deal with one contract, one point of contact and one invoice. You will receive consistent, consolidated feedback through your dedicated project manager.
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
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.
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.
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).
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
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.
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.
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 has extensive experience in writing safety documents and can support you with assessing a product’s risk benefit profile for your product.
Quality System and Audit
BlueReg experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations 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).
FDA GUIDANCE – COVID-19
BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...
EMA GUIDANCE – COVID-19
Given the support given to our clients in interactions with health authorities all around the...