Development Phase

  • IMPD (Investigational Medicinal Product Dossier)
  • IB (Investigator’s Brochure)
  • ISI (Integrated Summary of Immunogenicity)
  • Clinical Trial Application
  • IND
  • Orphan drug designation application
  • PIP (Paediatric Investigation Plan)
  • SME application

MAA, NDA/ BLA

CTD Modules 1-5

Specific Sections

 

Centralised Procedure at EMA

  • Contact point to EMA
  • Support for pre-submission meetings, procedure preparation and submission
  • Support in understanding the questions of the agency and preparation of responses
  • Preparation of SAG and CHMP oral explanations