Regulatory Services

Day Zero ehf offers various services in dossier compilation and preparation for submission:

Dossier Compilation

  • Dossier conversion to eCTD
  • Audit of the quality part of the dossier
  • Compiling of m2-m5
  • Compiling module 1

MA application

  • National Submissions
  • Mutual Recognition Procedures
  • Decentralised Procedures
  • Central Procedures

National Phase

  • Submission of national translation post procedure
  • Follow up of national phases
  • Price and reimbursement applications within Iceland

Life Cycle Management

  • Variations
  • Renewals
  • MAH transfers
  • Withdrawals
  • DCP splits
  • RMS transfers
  • Sunset Clause

Outside EU

  • CPP applications
  • GCC regional eCTD applications