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Drug-device combination products continue to drive innovative solutions for administering therapies to patients. However, the increasingly complex nature of these devices can make it challenging to develop a preclinical safety testing strategy and plan that meets regulatory requirements for both the drug and device.
WuXi AppTec Medical Device Testing’s experience in devices, pharmaceuticals and biologics provides customers with a comprehensive solution to achieving preclinical safety. After years of experience with hundreds of combination products, we know that each combination product is different and needs a plan to meet the expectations of global regulatory bodies.