Workflow Automation for Regulatory Documents
Automate Document Reviews & Approvals
Configurable workflows that match your regulatory processes. Route documents automatically, enforce compliance, and eliminate bottlenecks.
Document Upload
Protocol uploaded by R. Smith
Medical Review
Assigned to Dr. Johnson
Regulatory Review
In progress - L. Park
Final Approval
Pending VP sign-off
Workflow Capabilities
Everything you need to automate and enforce your regulatory processes
Smart Routing
Automatically route documents to the right reviewers based on document type, therapeutic area, or region.
Parallel Reviews
Send documents to multiple reviewers simultaneously to compress review cycles without sacrificing quality.
Auto-Escalation
Automatic reminders and escalations when deadlines approach or are missed. Never lose track of pending reviews.
E-Signatures
21 CFR Part 11 compliant electronic signatures integrated directly into approval workflows.
Business Rules
Define conditional logic for routing decisions, approval requirements, and compliance gates.
Real-Time Dashboards
See every document's status, identify bottlenecks, and track team performance at a glance.
Pre-Built Workflow Templates
Document Review
Standard review and approval workflows for regulatory documents
- Protocol review
- IB updates
- CSR review
- Labeling changes
Submission Preparation
Multi-stage workflows for submission assembly and quality review
- Document collection
- eCTD compilation
- Quality check
- Final sign-off
Change Control
Manage document changes with proper review and approval
- Change request
- Impact assessment
- Review cycle
- Implementation tracking
Agency Correspondence
Track and respond to agency queries systematically
- Query logging
- Response drafting
- Multi-department review
- Response submission
Connects With Your Tools
Workflows that span your entire regulatory ecosystem
Notifications & tasks
Calendar
Deadline sync
MS Teams
Chat notifications
REST API
Custom integrations
Ready to Automate Your Workflows?
See how DNXT can transform your regulatory document processes
