Regulatory Solutions for
Pharmaceutical Companies
Manage 50+ products across multiple markets. Submit to FDA, EMA, PMDA, NMPA simultaneously with 60% faster cycle times.
The Pharmaceutical Challenge
Managing regulatory submissions for large pharmaceutical portfolios is complex, time-consuming, and high-risk
Complex Global Portfolios
Managing 50+ products across 30+ markets with different regulatory requirements for each region
Multi-Agency Submissions
Coordinating simultaneous submissions to FDA, EMA, PMDA, NMPA with varying formats and timelines
Version Control Nightmare
Tracking changes across 1000+ documents with multiple versions, translations, and regional variants
The DossiAIr Solution
Enterprise-grade platform with 5-layer intelligence designed for large pharmaceutical companies
Multi-Product Portfolio Management
Manage unlimited products and submissions from a single dashboard. Track status, compliance, and deadlines across your entire portfolio with product-level data isolation.
- Unlimited products and submissions
- Portfolio-wide compliance dashboard
- Cross-product document reuse (80%+ reuse rate)
- Centralized document library with automatic classification
Multi-Product Portfolio Management Visualization
Simultaneous Multi-Agency Submissions
Submit to FDA, EMA, PMDA, NMPA, Health Canada, MHRA, and TGA simultaneously with 3,400+ agency-specific regulatory prompts and compliance checks.
- 7 global agencies supported (FDA, EMA, PMDA, NMPA, HC, MHRA, TGA)
- Pre-configured agency templates with automatic format conversion
- Agency-specific validation rules and terminology
- 50+ ICH guidelines integrated for compliance
Simultaneous Multi-Agency Submissions Visualization
Conversational AI - Chat with Submission
Ask questions about your submission in natural language. Get instant answers about status, compliance issues, content location, and regulatory intelligence.
- Natural language queries: "What compliance issues in Module 3?"
- Context-aware responses with full submission knowledge
- <3 second response time with RAG technology
- Proactive insights and gap identification
Conversational AI - Chat with Submission Visualization
Enterprise Version Control & Change Management
Track every change across all documents with full audit trails, automatic change detection, and impact analysis across linked sections.
- Document-level version control with SHA256 change detection
- Complete audit trails (21 CFR Part 11 compliant)
- Change impact analysis: "Table X updated → Used in 3 sections"
- Automated update propagation with user approval
Enterprise Version Control & Change Management Visualization
Advanced Collaboration & Access Control
Enable teams across departments and geographies to collaborate securely with role-based access, real-time editing, and electronic signatures.
- Role-based access control (RBAC) with department-level permissions
- Real-time collaboration with WebSocket technology
- Comment and review workflows with approval routing
- Electronic signatures for digital document approval
Advanced Collaboration & Access Control Visualization
Measurable ROI for Enterprise
Real results from pharmaceutical companies using DossiAIr
Faster NDA/MAA
6 months → 2.4 months
Annual Savings
Per regulatory team
First-Time Approval
ICH compliance guaranteed
ROI Calculator
Calculate your potential savings with DossiAIr
Current State (Annual):
- Average submissions per year:10
- Hours per submission:500 hrs
- Average hourly cost:$150/hr
- Total annual cost:$750,000
With DossiAIr (Annual):
- Average submissions per year:10
- Hours per submission (60% faster):200 hrs
- Platform cost:$24K/yr
- Total annual cost:$324,000
Global Pharma Corp Success Story
The Challenge
Global Pharma Corp, a Fortune 500 pharmaceutical company with 50+ marketed drugs, was struggling with their regulatory submission process. They faced:
- ✗6-month average NDA submission preparation time
- ✗Manual document classification taking 100+ hours
- ✗30% error rate in cross-references
- ✗Difficulty tracking versions across global teams
- ✗Compliance issues with agency-specific requirements
The Results
After implementing DossiAIr's 5-layer intelligence system, Global Pharma Corp achieved:
- ✓60% reduction in submission time (6 months → 2.4 months)
- ✓$250K annual savings per regulatory team
- ✓95% first-time approval rate
- ✓Zero compliance violations in 12 months
- ✓50% reduction in manual errors
"DossiAIr transformed our regulatory operations. The AI classification alone saved us 100 hours per submission. We're now submitting to multiple agencies simultaneously with confidence."
From Assistive AI to Agentic AI
The future of regulatory automation: fully autonomous submission creation and maintenance
Today: Assistive AI
Human-in-the-loop AI that amplifies regulatory team capabilities
- →Generates draft content for human review
- →Suggests cross-references for validation
- →Identifies compliance issues for resolution
- →30% human involvement for decisions
2027+: Agentic AI
Autonomous regulatory agents that handle end-to-end submission lifecycle
- ✓Autonomously gathers all supporting materials
- ✓Assembles complete dossier without human input
- ✓Validates compliance and fixes issues automatically
- ✓5% human involvement (final approval only)
Submission Creation
2-3 days → 4-6 hours
Human Involvement
Review only, not creation
Compliance Score
Near-perfect accuracy
Per Submission
$50K → $5K
Enterprise Features
Everything large pharmaceutical companies need today
Unlimited Products
Manage unlimited products and submissions with product-level isolation
7 Global Agencies
FDA, EMA, PMDA, NMPA, Health Canada, MHRA, TGA with 3,400+ prompts
Advanced Analytics
Portfolio-wide compliance insights and submission tracking
SSO & RBAC
Enterprise security with role-based access control
REST API Access
Integrate with your existing regulatory systems
24/7 Enterprise Support
Dedicated account manager and priority support
Ready to Transform Your
Regulatory Operations?
Join leading pharmaceutical companies automating their regulatory submissions