Global Regulatory Consulting and Convergence Product Regulatory Approval
Considering the characteristics of convergence products that combine pharmaceuticals and medical devices, Meditip provides customized consulting spanning the entire lifecycle, from global regulatory strategy development to regulatory approval response in major countries such as FDA, EMA, and CE.
Overseas Certification
Through Gap Analysis, preliminary meetings, and approval strategy development aligned with US FDA and European EMA/CE MDR standards, we support the entry of convergence products into the global market.
Pharmaceuticals
Key Services
- FDA / EMA Gap Analysis
- FDA / EMA IND (Phase I & II)
- FDA / EMA Pre-IND Meeting
Medical Devices
Key Services
- FDA Gap Analysis
- CE MDR Gap Analysis
- FDA Pre-submission
- CE MDR
- FDA 510(k)
- ISO 13485
Convergence Products
Key Services
- Drug + Medical Device Combination Product Development and Approval Strategy
- Overseas Approval Roadmap Development
- Global Regulatory Agency Response