Specific Services for Europe

Our market specific services for Europe

BlueReg has a dedicated European team of over 15 consultants who cover the whole development process as a consultant or operational support, from concept to approval, on centralized or multi-national projects. Our experts are based in France and in the UK. They hold a flexible skill set ranging from regulatory strategy to operational execution, as well as leading and managing regulatory projects.

They can provide expertise on all the following services and activities

  • Regulatory advice on development
  • Interactions with regulatory agencies
  • Clinical Trial Application (CTA)
  • Scientific Advice (EMA or national agencies)
  • Orphan Drug Designation (ODD)
  • Paediatric Investigation Plan (PIP)
  • Drug registration and registration strategy
  • MAA dossier preparation
  • Post MAA regulatory maintenance
  • Regulatory publishing

Coordination and regulatory support across Europe

This service is utilised by small start-up companies or companies that have not yet had a product reach the EU market. They generally have no in-country regulatory resource. This service may also be of interest to medium sized companies who do not have presence in all EU countries.

This service can be used 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 have a network of partners around the world. All our partners are fully qualified and have significant experience in their area and market

You only need to deal with one contract, one point of contact, one invoice and you will receive consistent consolidated feedback.

We will discuss your needs and co-ordinate the collection of the information or provision of services with our partners.

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