There are many tools in the regulatory toolbox, we will help you find the ones suitable for your product and geographic area (US and EU):

  • Planning, preparation, application and participation in regulatory interactions such as FDA pre-IND, and EoP2-meeting as well as national and centralized EU scientific advice
  • Regulatory, incentives
  • Paediatric investigational strategy and application
  • Orphan drug strategy and application
  • Advice on potential use of regulatory pathways to support innovative products, e.g PRIME (EU) and Breakthrough Designation (US)
  • Small and medium-sized enterprise (SME)-status, information about benefits and qualification requirements