Our market specific services for the United States
The Food and Drug Administration (FDA) is responsible for protecting and promoting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices.
Our consultants can help navigate FDA regulations and provide support and advice for all your project requirements.
Specific services provided by our team include:
- Pre-Market Notification (510(k))
- Pre-Market Approval (PMA)
- Investigational New Drug application (IND)
- New Drug Application (NDAs)
- Biologics License Application (BLAs)
- Pediatric Study Plans / Orphan Drug Designation
- Submission to the FDA (Electronic Submission Gateway)
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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.
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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).
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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
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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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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).
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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
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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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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Audits
BlueReg can assist with all your audit requirements and can provide a complete audit preparation package which we can tailor to your needs.
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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).
Associated News
Benefits of using a third party Exploitant to run early access programs in France and more
Main benefits of outsourcing "Exploitant" status : Reminder : French regulatory authorities require having an...