Automated vs Manual Regulatory Submissions

The True Cost of Manual Submissions

See what manual regulatory processes are really costing your organization

Automated

Manual

Process Step	DNXT Automated	Manual Process
Document Collection	Centralized repository with version control	Scattered across email, SharePoint, local drives
eCTD Validation	Real-time as documents are added	Manual check at end, often missed errors
PDF Compliance	Automatic validation and fixing	Manual review of each document
Hyperlink Verification	Automated link checking	Click-through testing (hours of work)
Audit Trail	Automatic complete history	Manual logging (often incomplete)
Version Control	Built-in with full history	File naming conventions (error-prone)
Multi-Region Submissions	Single source with regional rules	Duplicate work for each region
Error Detection	Immediate with resolution guidance	Discovered during agency review
Team Collaboration	Real-time with workflows	Email chains and status meetings
Submission Assembly	Minutes with automation	Days of manual assembly

3.5 days

3.5 Days

Average time from document collection to submission-ready eCTD package

14 days

14 Days

Industry average for manual submission preparation and validation

Beyond time and cost, manual processes introduce significant risk to your regulatory operations

15% of manual submissions face technical rejection, delaying approvals by months and costing millions.

Wrong document versions, broken links, and validation errors that automated systems catch instantly.

Last-minute scrambles and weekend work lead to turnover in experienced regulatory professionals.

See what automation could save your organization based on your submission volume

Average submissions per year 25

Hours saved per submission 84 hours

Annual hours reclaimed 2,100 hours

Estimated annual savings $420,000+

See DNXT Publisher in action and start reclaiming your team's time