Ensure full EU and global regulatory compliance for your medical products with expert guidance.
Overview
Globaxa’s regulatory services team provides end-to-end support for pharmaceutical product registration, lifecycle management, and health authority interactions across global markets. Our deep regulatory expertise ensures your products achieve market authorization efficiently while maintaining ongoing compliance.
Core Regulatory Services
Product Registration & Marketing Authorization
- New product registration strategy
- Regulatory pathway assessment and recommendation
- Dossier compilation and submission
- Health authority queries management
- Marketing authorization acquisition
- Post-approval variation management
Regulatory Intelligence
- Country-specific requirement analysis
- Regulatory landscape monitoring
- Competitive intelligence
- Guideline interpretation
- Regulatory strategy development
Compliance Services
- Regulatory compliance audits
- SOP review and development
- Training program design
- Mock inspections
- CAPA implementation support
- Quality system enhancement