Dossier Submissions Pre-check
Validate regulatory submissions before filing with AI-powered pre-checks to reduce rejections and accelerate approvals.
Key Benefits
Comprehensive Validation
Check dossiers against CTD format, ICH guidelines, and regional requirements
Error Detection
Identify gaps, inconsistencies, and missing information before submission
Faster Approvals
Reduce rejection rates and accelerate time to market
Quality Assurance
Ensure submission quality and completeness with AI validation
How It Works
1
Upload Dossier
Upload your complete dossier or individual modules for pre-check
2
Data & Document Validation
Comprehensive analysis against regulatory requirements, Underlying RIMS, QMS, Clinical or Toxicology Data and industry standards
3
Real-time Review Findings
Get detailed reports highlighting gaps, errors, and improvement areas
4
Submit with Confidence
Address issues and submit a complete, compliant dossier