Global Market Entry and Overseas Certification Strategy Consulting
Considering the characteristics of pharmaceuticals, biopharmaceuticals, medical devices, and IVD, Meditip provides customized consulting across the entire global registration cycle, from country-specific regulatory strategy development and overseas certification to local partner linkage and market entry.
Overseas Certification and Country-Specific Regulatory Response
From US FDA, Europe EMA/CE, China NMPA, and Japan PMDA to Southeast Asia registration, we provide approval strategies and registration services optimized for each country's regulatory authority.
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Pharmaceuticals / Biopharmaceuticals
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NDA / BLA
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IND / Pre-IND Meeting
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DMF Support
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FDA / EMA / NMPA / PMDA
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Medical Devices
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FDA PMA / 510(k)
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MDR (CE)
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NMPA / PMDA
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SEA Registration
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ISO 13485
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IVD (In Vitro Diagnostic Medical Devices)
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FDA PMA / 510(k)
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IVDR (CE)
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NMPA / PMDA
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SEA Registration
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Global Offices & Service Coverage
Based on the Tigermed Family Group's global network, local offices in major markets worldwide, and strategic partnerships, we support fast and reliable global market entry, from country-specific regulatory response to overseas certification, local registration, and operations.
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Global Employees
10,000 +
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Global Customers
2,700 +
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Global Locations & Service Networks
180 +
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Innovative Drugs Supported
72 +