BlueReg has a dedicated team of experts who cover the whole development process from concept to approval, on centralised and multi-national projects.
Our consultants have diverse experience ranging from regulatory strategy to operational execution and full project management support will be provided.
This service can be utilised during the entire registration process, through to launch and post marketing activities. BlueReg can guide you through the country to country requirements for local regulatory strategy, launch preparation, promotional copy review, healthcare compliance, pharmacovigilance, quality, supply chain, labelling review, pricing and reimbursement and post-approval submissions.
We provide local in-country resources and support as required.
Support is provided through our in-house team utilising, when required, the support of our qualified worldwide partner network who have significant national experience. BlueReg will provide full project management for all engagements from single market to multi-country / multi-regional projects with assignment of a designated project lead.
Our services can supplement client in-country resources or we can undertake all market activities on your behalf as required.
Services provided by our team include:
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..
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).
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).
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.
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.