eCTD Hub user manual

eCTD Hub is for regulatory affairs teams that submit to the SFDA and the other GCC authorities. It covers GCC Module 1 v1.5 with validation criteria v1.4.

Getting started

Create your company workspace, sign in, find things with search, and set your language and theme.

Administration

Invite colleagues, give them roles, and connect your email and identity provider.

Products and sequences

Build the CTD tree, upload documents, validate, approve with an e-signature and publish.

Troubleshooting

Every error message, what it means and what to do.

Security and data

Tenant isolation, encryption and sessions.

Release notes

What the beta includes.