Submissions Built from
Live Data
Stop assembling submissions from static documents. Build them from the same structured data your development and quality teams already maintain.
Regulatory Capabilities
Assemble CTD Module 3 sections directly from structured CMC and Quality data. No copy-paste, no version conflicts. The submission reflects the current state of your development records.
When a manufacturing parameter changes, instantly see which regulatory filings, specifications, and stability protocols are affected. Catch inconsistencies before they become rejection letters.
Manage submissions across multiple Health Authorities from a single data source. Track market-specific requirements, variation timelines, and approval status without parallel spreadsheets.
Map your data directly to ICH guideline requirements (Q1–Q14). Know exactly which data supports which guideline section, and identify gaps before your assessor does.
What Changes
- Reduce submission preparation time by eliminating manual data gathering and reconciliation
- Detect regulatory impact of upstream changes in real time, not during filing review
- Maintain a live audit trail of every data point that feeds into your submissions
- Track variation lifecycle across multiple markets from a single dashboard
- Ensure consistency between Module 3 and Quality sections automatically
- Generate assessment-ready data packages that accelerate Health Authority review
Fed by Upstream Data
Regulatory filings pull directly from CMC development records and Quality specifications. One data layer, zero reconciliation.
See Regulatory Affairs In Action
We'll walk through the module with your own submission scenarios.
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