Market Specific Services

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.

We will provide a flexible approach designed to fully support your needs which will be adapted as the project evolves. All activities are carried out in compliance with local and regional regulatory requirements.

Your requirements for support and the time to engage with BlueReg

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.

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Market Specific Component Services

Services provided by our team include:

 

  • Development strategy and advice
  • Interactions with regulatory agencies
  • Clinical Trial Applications (CTAs)
  • Scientific Advice (European Medicines Agency and national agencies)
  • Orphan Drug Designations (ODDs)
  • Paediatric Investigation Plans (PIPs)

 

 

 

  • Drug registration and registration strategy
  • Marketing Autorisation Application (MAA) dossier preparation
  • Post MAA regulatory maintenance
  • Regulatory publishing
  • Regulatory support
  • Local in-country support services and regulatory support

“It is really incredible, how perfectly all has worked out, and we found for all challenges pragmatic but fully compliant solutions. This is extraordinary and an excelling result, we all can be very proud of.”

Associated services

We provide local in-country resources and centralised regulatory support, as required, for all manner of market specific services.
Support is provided through our in-house team utilising, when required, the support of our qualified Global Partner Network who have significant national experience. BlueReg provides full project management for all engagements from single market to multi-country / multi-regional projects with assignment of a designated project lead.

Associated services

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).

Associated services

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).

Associated services

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.

Associated services

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.

Associated services

Worldwide

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


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