Streamline FDA Documentation Workflows
Organize promotional materials and supporting references for FDA submissions. AI assists with claim extraction and reference linking. Human review always required.
Important: This is Not a Compliance Validation Tool
- • Does not validate FDA compliance - Your regulatory team must review all materials
- • Does not replace MLR review - Human regulatory review is always required
- • Workflow tool only - Helps organize documentation, not guarantee compliance
The Challenge of FDA Documentation
Common FDA Documentation Requirements
- • Organized reference packs for all promotional claims
- • Clear linking between claims and supporting evidence
- • Complete audit trails of document changes
- • Team collaboration with approval workflows
- • Version control for all materials
- • Timestamped documentation for regulatory submissions
How PromoPack Helps Your Workflow
AI-Assisted Claim Extraction
Upload your promotional materials and let AI help identify medical claims. All AI suggestions require human review and validation by your regulatory team.
Reduces Manual Entry
AI suggests claims from your documents, reducing time spent on copy-paste tasks.
Always Reviewable
All extracted claims can be edited, approved, or rejected by your team.
PubMed Integration
Search PubMed directly to find and link supporting references.
Reference Linking
Connect claims to supporting documents with clear visual organization.
Audit Trail Documentation
Maintain audit trails for every promotional material. Track reviews, approvals, and modifications with timestamped documentation suitable for regulatory submissions.
Documentation Organization
Organize all supporting materials in one place. Generate reference packs suitable for FDA submissions with proper formatting and document tracking.
What this tool provides for FDA workflows:
- Centralized storage for promotional materials and references
- Structured organization of claims and supporting evidence
- PDF generation for reference packs
- Audit trails and version history for regulatory documentation
Workflow Features
Try Our Documentation Workflow
See how PromoPack can streamline your FDA documentation process
Try Interactive DemoNo account required • Explore with sample data