eCTD tool in development
Regulatory affairs & eCTD project
We are working on an eCTD tool to explore support for regulatory document workflows. Development is ongoing, with functional scope and validation requirements still to be defined.
Topics to scope together
- Discuss document workflows and constraints
- Scope requirements with your regulatory teams
- Define evaluation conditions for a future pilot
Scope and limits
No commercial availability, validated compliance, authority acceptance or submission service is announced. Regulatory responsibilities and required expertise must be established for each project.
Possible deliverable, subject to agreement
An agreed pilot scope and evaluation plan; no delivery date or certification is promised.
Discuss this topic