Multi-country regulatory submissions, approvals, and activation tracking.
The Country Activations module manages the regulatory submission and approval process across multiple countries and regions. Track regulatory requirements per country, submission status, approval timelines, and country-specific documentation. The module ensures compliance with local regulations while providing a unified view of global activation status.
Explore the module's workflow through interactive interface mockups showing each step of the process.
Track regulatory submission and approval status across all countries involved in the trial.
| Country | Authority | Submission Date | Approval Date | Status |
|---|---|---|---|---|
| USA | FDA | Jan 10, 2024 | Feb 28, 2024 | Approved |
| India | CDSCO | Jan 15, 2024 | Mar 05, 2024 | Approved |
| Japan | PMDA | Jan 20, 2024 | Apr 02, 2024 | Approved |
| Germany | BfArM | Feb 01, 2024 | — | Under Review |
| Sweden | Läkemedelsverket | Feb 01, 2024 | — | Query Response |
Track submissions through preparation, review, submission, and approval stages.
Germany — BfArM
CTA Submission
Sweden — LMV
Query Response Due
France — ANSM
Document Preparation
Brazil — ANVISA
Submission Ready
USA — FDA
IND Approved
Overview of global activation status with country count, approval rate, and timeline metrics.
Countries Submitted
8
5 approved, 3 pending
Mean Approval Time
48 days
Within 60-day target
Regulatory Queries
3
1 overdue
Sites Activated
42
across 5 countries
How Country Activations integrates with other CTMS modules in the platform.
Country approval gates site activation
Study protocol drives country submissions
Submission documents stored in vault
Regulatory milestones tracked per country
Regulatory portal submissions via API