Drug Development
Consulting

Drug development consulting

You can rely on our regulatory intelligence as well as on the experience and expertise of our consultants for the success of your project. We can provide you with an end-to-end project plan to guide you from the development of your product right through to authorisation and beyond. Some of the services we offer include:

 

  • Strategic input and regulatory advice on development
  • Assessment, utilisation and positioning of available data
  • Advice on global non-clinical and clinical development plans
  • Clinical Trial Application (CTA)
  • Scientific Advice (EMA or national agencies)
  • Orphan Drug Designation (ODD)
  • Paediatric Investigation Plan (PIP)
  • ‘Due diligence’ for licencing or investment decision making

 

Drug

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