Ensure full EU and global regulatory compliance for your medical products with expert guidance.
Overview
Globaxa specializes in the preparation of comprehensive regulatory dossiers in various international formats including the Common Technical Document (CTD), ASEAN Common Technical Dossier (ACTD), and Drug Control Review (DCR) formats. Our experienced regulatory writers ensure your submissions meet the highest standards of quality and completeness.
Our Dossier Services
Document Management
- Electronic document management system (eDMS)
- Version control and tracking
- Archival and retrieval systems
- eCTD publishing and validation
Quality Assurance
- Internal review and quality checks
- Cross-referencing validation
- Consistency verification
- Compliance assessment
- Final submission review
Publishing Services
- eCTD sequence creation
- Electronic submission formatting
- Validation against regulatory requirements
- Gateway submission support
- Confirmation of successful submission