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)
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..
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
United Kingdom and Ireland
Looking for help and support in entering the UK or Irish markets? Unclear how Brexit will impact on the UK position within medicines regulation in Europe? 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) or Republic of Ireland Health Products Regulatory Authority (HPRA).
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.
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).
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.
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.
BlueReg assists companies to plan and submit any necessary changes to existing marketing authorisations 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.
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.
BlueReg can assist with all your audit requirements and can provide a complete audit preparation package which we can tailor to your needs.
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.
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 .
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).
FDA GUIDANCE – COVID-19
BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...
News - 24 April 2020
BlueReg continues to expand in the US opening its second North American office in Boston.
Cambridge, Massachusetts, USA, December 13 2019, BlueReg, the consulting organization for life sciences companies, is...
News - 13 January 2020