Animal Health
The animal health market holds significant opportunities but regulatory complexity and limited guidance make it challenging to navigate. That is precisely where One Health Compliance steps in.
One Health Compliance has deep expertise in the specific regulatory requirements for medical devices and in vitro diagnostics in veterinary medicine – companion animals, horses and livestock.
Our veterinary expertise covers the full regulatory cycle: product qualification and classification, market access strategy (Europe, United States, international), leveraging existing data and supporting exchanges with competent authorities.
What makes this expertise particularly valuable: our ability to identify synergies between human and veterinary data, in both directions. An innovation validated in human health can open veterinary opportunities and vice versa, as illustrated during the COVID crisis, when the veterinary industry played a key role in the rapid production of rapid diagnostic tests.
International Reference :
Animal Health Europe and Health for Animals, two reference associations representing manufacturers of veterinary pharmaceuticals, vaccines and other animal health products, have called on One Health Compliance for work on the regulation of veterinary medical devices and diagnostics.
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100 +
countriesVeterinary diagnostic regulatory requirements mapped as part of a mission for Diagnostics for Animals, used by global industry leaders and presented in exchanges with the WOAH.
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100 %
Of responses submitted to regulatory authorities and notified bodies have been accepted.
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Human Health
20 years of experience in medical devices, in vitro diagnostics and care products: from regulatory feasibility to the resolution of the most complex situations.
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What Makes Us Unique
A dual human–animal expertise, an integrated strategic vision and a specialisation in the rapid resolution of uncertainties: three defining features of the One Health Compliance approach.
