Day Zero ehf offers various services in dossier compilation and preparation for submission. We have extensive experience working with a number of different RMS in the DCP/ MRP procedures and can provide regulatory information, to help you choose the best RMS for your product.

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
- RMS transfers
- Sunset Clause