Specific Services for Europe

BlueReg has a dedicated team of experts who cover the whole development process from concept to approval, on centralized and multi-national projects.

 

Our consultants have diverse experience ranging from regulatory strategy to operational execution and full project management support will be provided.

Services provided by our team:

 

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

 

 

 

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

Coordination and regulatory support across Europe 

This service can be utilized 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 utilizing, 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.

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.

Coordination and regulatory support across Europe – 1@2x

Our experts

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