SCOPE OF WORK
– To transform from hard copies to eCTD format a portfolio of 100 Marketing authorisations
– To submit 50% of them to EMA
– Works conducted remotely
DURATION & INVOICING
- Duration: 2-year contract
- Gap assessment invoiced on an hourly rate
- Updates of MAAs: workpackage
- Archiving: Annual fee
OUTCOMES
- Scanning and Archiving of hard copies
- Gap assessment of the existing MAs and ICH Requirements
- Updates of MAs, reformating and CTD naming
- Submission