CRED ERP 25

01/07/2025

Scheduling your submission (2)

• Build in time for eCTD compilation and publishing

• Need to balance business/ marketing strategy vs. strategic considerations & technical risks • Premature submission vs. delayed filing • Build-in quality from beginning • Internal resource to respond to validations/ scientific questions

The Organisation for Professionals in Regulatory Affairs

5

Scheduling your submission (3)

Be honest and transparent • Realistic vs. stretch goals • Best guess vs. worst case • Filing dates vs. approval dates

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• Confirm centralised eligibility (if needed)

• Submit ‘Intent to File Notification’ or book the RMS ‘slot’ (decentralised procedure) (common request form)

The Organisation for Professionals in Regulatory Affairs

6

3