Pharmacovigilance

BlueReg can support with routine pharmacovigilance (PV) activities for early access programs, clinical trials or post-marketing. The team can support you with : 

• PV case processing (recordings, database entry, case translation and follow-up)
• Establish causality assessment for PV cases
• Submission to competent authorities
• Literature review

“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 Patron

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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Product Registration in the US & EU

Do you want to register your healthcare product in the United States or the European Union? BlueReg has a team whose expertise covers the entire development process, from concept to marketing authorization, on centralized and / or multinational projects. Our consultants have varied experience ranging from regulatory strategy to operational execution.

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International Registration

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, supported by the expertise of our consultants and our international qualified partners.

 

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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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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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CTD Dossier Writing

BlueReg can collaborate with your experts to author, review and update your Common Technical Document (CTD) as required for new Marketing Authorisation Application (MAA) submissions or during the lifecycle of the medicinal product.

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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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Pharmacovigilance

BlueReg can support with routine pharmacovigilance activities for early access programs, clinical trials or post-marketing

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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 and CTD 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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Specific Services for Europe

BlueReg has a dedicated team who cover the whole development process from concept to approval, on centralized or multi-national projects. Our consultants have diverse experience ranging from regulatory strategy to operational execution and full project management support will be provided.

Associated services

Specific Services for the United States

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

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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BlueReg’s team will be pleased to meet you at BioFit Lille, on booth F10

Event location: Lille, France  Event date: Tuesday, December 4, 2018 to Wednesday, December 5, 2018 ...

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