Market Specific Services

Audits Brexit Drug Registration and Regulatory Roadmap Early & Expanded Access Programs in France Exploitant Services Market Access France Pharmacovigilance Pricing and reimbursement (Drugs and Medical devices) Product Quality Review Promotional Material Review in France Regulatory Affairs Consulting EU Regulatory affairs consulting in France Role of Responsible Pharmacists in France United Kingdom United States Worldwide

Promotional Material Review

The BlueReg team of experienced consultants can provide full support to meet your business objectives, whilst ensuring full compliance to the regulatory requirements in France.

Our services include:

Regulatory advice and review of promotional materials, websites, training documents and e-health applications
Submission to the French National Agency for the Safety of Medicines and Health Products (ANSM) to obtain “visas” for promotional materials
Defining and implementation of processes and procedures relevant to the creation, review, and approval of promotional and advertising materials for the French market

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Regulatory affairs consulting in France

The BlueReg team have a highly successful track record of delivering all French market specific services, from the simple to the complex providing expert advice as well as hands-on operational support.

Pharmaceutical consulting for life sciences industry

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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).

Regulatory affairs Electronic submission

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Promotional Material Review in France

BlueReg peut vous accompagner pour du conseil ou de la gestion opérationnelle afin de garantir la conformité de toutes vos opérations avec les exigences qui s’appliquent en France

Pharmaceutical industry Food and Drug Administration

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United Kingdom

Looking for help and support in entering the UK? Our UK based consultants can provide support and advice for all your project requirements in relation to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Medicines and Healthcare products Regulatory Agency Regulatory agency

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United States

Looking for help with regulatory activities in the United States? BlueReg can help to navigate the Food and Drug Administration (FDA) regulations and provide support and advice for all your project requirements.

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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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Exploitant Services

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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.

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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.

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Brexit

BlueReg assists companies to plan and submit any necessary changes to existing marketing authorizations before the end of the Brexit transition period in order to comply with EU law. Please contact us or follow our BlueReg Linkedin page to be kept up to date with the Medicines and Healthcare products Regulatory Agency (MHRA) Brexit guidance as they are issued.

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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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Regulatory Affairs Consulting EU

Our team composed of global experts from the pharmaceutical industry provides the necessary support to help you succeed in all regulatory aspects of life sciences in Europe from development, registration through to commercialization.

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Early & Expanded Access Programs in France

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 projects 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).