Extending a Molecular Diagnostic Platform to the Veterinary Market: Regulatory Strategy Across 32 Countries for an Executive Committee Decision

Context

A large international company wanted to assess the feasibility of extending its molecular diagnostic platform — already approved in human health — to the veterinary market, across 32 countries including Europe and the United States. A GO/NO GO decision had to be presented to the executive committee within very tight deadlines.

The challenge

The company needed a comprehensive regulatory strategy integrating the specificities of each target market, the possibilities of reusing existing human data, and the options for early interactions with authorities. All within a timeline enabling an informed executive committee decision.

The One Health Compliance solution

• Delivery of a tailored regulatory strategy covering 32 countries with country-by-country identification of requirements, optimisation of human-to-veterinary data synergies, and recommendations for early interactions with authorities, including the USDA.

The result

• The executive committee had all the elements needed to make its decision within the required timeframe.

✓ Comprehensive strategy across 32 countries ✓ Human-animal synergies identified ✓ GO/NO GO decision made on time

Does your situation share similarities with this case? Feel free to get in touch to discuss it.

Sandra Dejean, PharmD – Founder of One Health Compliance

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