Welcome to BlueReg

We are an international pharma consultancy offering strategic regulatory advice and hands-on outsourcing solutions to life sciences companies through services with everything from Product development to Life cycle management, Early Access Programmes and more

  • Discover our popular Exploitant services

    PharmaBlue is part of the BlueReg family and supports Pharma companies looking to market their medicinal products in France through our Early Access Programmes, specifically Temporary Authorisation for Use (ATU)

  • Strategic services

    to guarantee you the best of your values

    Registration Strategy

    BlueReg has a wealth and variety of experienced consultants who will provide you with valuable and realistic advice and support for your drug registration strategy.

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    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.

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    Scientific Advice and Interaction with Health Regulatory Agencies

    BlueReg has extensive experience in scientific advice with the European Medicines Agency (EMA) and many national competent authorities. BlueReg can assist with all competent authority meetings.

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    Publishing & submissions

    BlueReg is your strategic partner to meet your goals in publishing activities and regulatory submissions worldwide. BlueReg provides a broad range of services for electronic Submissions (eSubmissions). You can rely on the BlueReg experienced team and efficient use of publishing and formatting tools to prepare your dossiers/documents according to Health Authority requirements. 

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    Scientific & Dossier Writing

    BlueReg provide flexible solutions for scientific writing covering all kinds of engagements or operational platforms to meet your company’s needs from product development, registration through to launch and product maintenance activities.  Our team are experienced in writing clinical modules for submission in the EU and the US, PIPs, ODDs, INDs, IMPDs and IBs, as well as briefing packages for scientific advice.  The team also manage Chemistry Manufacturing and Controls (CMC) writing for chemical and biological products.

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    CMC Regulatory support

    Our CMC Regulatory support services include everything from regulatory strategy and preparation of meetings with health authorities, assessment and preparation of regulatory documents, responses to agency questions, maintenance of products on market, regulatory compliance strategy worldwide and geographical roll out.

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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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    Promotional 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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    Early Access Programmes (ATU)

    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 (ATU) projects (nominative and cohort) in France

    Learn more
    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).

    Learn more

    BlueReg has a wealth and variety of experienced consultants who will provide you with valuable and realistic advice and support for your drug registration strategy.

    Learn more

    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.

    Learn more

    BlueReg has extensive experience in scientific advice with the European Medicines Agency (EMA) and many national competent authorities. BlueReg can assist with all competent authority meetings.

    Learn more

    BlueReg is your strategic partner to meet your goals in publishing activities and regulatory submissions worldwide. BlueReg provides a broad range of services for electronic Submissions (eSubmissions). You can rely on the BlueReg experienced team and efficient use of publishing and formatting tools to prepare your dossiers/documents according to Health Authority requirements. 

    Learn more

    BlueReg provide flexible solutions for scientific writing covering all kinds of engagements or operational platforms to meet your company’s needs from product development, registration through to launch and product maintenance activities.  Our team are experienced in writing clinical modules for submission in the EU and the US, PIPs, ODDs, INDs, IMPDs and IBs, as well as briefing packages for scientific advice.  The team also manage Chemistry Manufacturing and Controls (CMC) writing for chemical and biological products.

    Learn more

    Our CMC Regulatory support services include everything from regulatory strategy and preparation of meetings with health authorities, assessment and preparation of regulatory documents, responses to agency questions, maintenance of products on market, regulatory compliance strategy worldwide and geographical roll out.

    Learn more

    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.

    Learn more

    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.

    Learn more

    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 (ATU) projects (nominative and cohort) in France

    Learn more

    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).

    Learn more

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