Safety reports

BlueReg has extensive experience in writing safety documents in a wide variety of settings and different stages of the product lifecycle.

 

The experienced team can support with assessing a product risk benefit profile and writing a Risk Management Plan (RMP), Development Safety Update Report (DSUR), Periodic Benefit-Risk Evaluation Report  (PBRER) and early access reports. Furthermore, BlueReg can provide support to update the Summary of Product Characteristics (SmPC) for safety reasons.

 

All these activities are carried out in full compliance with Good Vigilance Practices and local standards.

Our experts

Our team can also support you through the entire application process from development, to registration and post-approval management

Dominique Patrone

Marie Regnat Sauvageon

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Worldwide

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

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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.

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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.

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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).

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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

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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.

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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.

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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.

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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. 

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Quality System and Audit

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

 

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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).

Associated News

The French system for preventing and managing shortages

The French regulation on the prevention and management of stock shortages of medicinal products is...

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New Appointment to our Leadership Team !

BlueReg Group is delighted to announce the appointment of Dominique Patrone as General Manager of PharmaBlue....

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EMA GUIDANCE – COVID-19

Given the support given to our clients in interactions with health authorities all around the...

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