Overview
The Common Technical Document provides a harmonized format for regulatory submissions, but each region has its own specific requirements, module variations, and technical specifications. Our multi-region publishing capability ensures your submissions are properly formatted for each target authority—FDA, EMA, Health Canada, Japan PMDA, and beyond. We maximize content reuse while ensuring each regional dossier meets local requirements.
Key Features
Our Process
Regional Planning
We review your global filing strategy and identify region-specific requirements for each target authority.
Core Dossier Development
We establish a core content set that can be adapted for regional requirements.
Regional Compilation
We compile region-specific versions with appropriate Module 1 content and technical specifications.
Coordinated Submission
We manage the timing and logistics of multi-region submissions according to your launch strategy.
Frequently Asked Questions
Relevant Regulatory Guidance
Why Choose Us
- Single partner for all your global publishing needs
- Consistent quality across all regional submissions
- Maximized content reuse with regional customization
- Understanding of region-specific requirements
- Coordinated timelines for synchronized global filings
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Schedule ConsultationWhat Our Clients Say
"We filed simultaneously in the US, EU, and Canada. Adelphi managed all three regional submissions, coordinating the timelines perfectly and handling each region's specific requirements. Their global publishing capability was essential to our launch strategy."
Dr. Klaus Schmidt
Global Regulatory Head
International Pharma
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