by admin | Dec 4, 2025 | Lab Notes
ABSTRACT – The promise of global drug development—conducting a single pivotal trial that supports simultaneous regulatory submissions across the United States, European Union, and United Kingdom—has collided with the reality of regulatory divergence. Despite...
by admin | Dec 4, 2025 | Lab Notes
ABSTRACT – The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have created an unprecedented certification bottleneck that threatens innovation, patient access, and the viability of medtech and biotech SMEs. With...
by admin | Nov 7, 2025 | Uncategorized
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