Specific Services for Europe and worldwide markets

Our market specific services for Europe and worldwide markets

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.

Services provided by our team include:

  • Development strategy and advice
  • Interactions with regulatory agencies
  • Clinical Trial Applications (CTAs)
  • Scientific Advice (EMA or national agencies)
  • Orphan Drug Designations (ODDs)
  • Paediatric Investigation Plans (PIPs)
  • Drug registration and registration strategy
  • 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 and worldwide markets

This service can be utilized during the entire registration process, through to launch and marketing of the product once it is approved. We can guide you through the country to country requirements for local regulatory strategy, post-approval submissions, launch preparation, promotional copy review, healthcare compliance, PV, quality, supply chain, labelling review and pricing and reimbursement.

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 worldwide partner network. All our partners are fully qualified and have significant national experience. BlueReg will provide full project management for all engagements from single market to multi-country / multi-region 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 needs evolve. All activities are carried out in compliance with local and regional regulatory requirements.

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