CRED Practical Document Writing and Management

What happens next…delivery.xml

Not just eCTD submissions: - ASMF PMF PSUR Repository Paediatric Signal detection VNeeS

Related sequence is always the first sequence in the regulatory activity for Human submissions. Helps agency

Identify whether a Risk Management Plan is included for: • MAA • Variation Type IB / II • Extension • PAM • Renewal

Can you spot the mistake here?

New button Variations for H&V: Type IA, Type IAIN, Type IB, Type II, Transfer MA, Notification 61-3 (H only)

PO should be filled out for invoicing purposes