In Vitro Diagnostic Development (IVD)

An integrated approach – from analytical validation through commercialization

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From the outset, our focus is on ensuring that your IVD is accurate, easily administered and readily available to the patients who need it—and these requirements guide our development strategy and subsequent study implementation. 

Our development design team, led by our regulatory affairs professionals, works with you to devise an optimized development path that meets your clinical and commercialization objectives. This plan translates into the seamless flow of pre-clinical and clinical activities required for an efficient and successful product launch. Because market considerations are infused into the plan, the evidence gathered will provide the edge you need in your product’s target therapy area.

And, once your product is on the market, we are available to help you preserve its value with a range of commercial services.

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