Market specific services and time to engage with BlueReg

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.

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

The ability to plan and execute regulatory and registration activities can mean the difference between missing a window of opportunity to provide patients with the new product or therapy on offer or losing out on the opportunity to a competitor.  BlueReg has a team of consultants able to support clients in any international market.