Unblocking an Urgent USDA Regulatory Approval: An Unexpected Solution Found Within Days

Context

A large international company had planned the commercialisation of a veterinary diagnostic in several countries. An unexpected block from the US regulatory authority competent for veterinary diagnostics (USDA) arose at the last minute: an unanticipated requirement directly threatened the launch timeline.

The challenge

Finding a solution urgently in a particularly complex context: European requirements do not provide for an official market authorisation attestation for this type of product, making the US request seemingly impossible to meet within the available timeframe.

The One Health Compliance solution

• Identification of an unexpected strategic option: obtaining an attestation from a competent authority in a European Union member state, presentable to the USDA.
• One Health Compliance secured the signature of an official document, drafted and argued without any modification. A substantiated response letter was then provided to the USDA.

The result

• The USDA accepted the elements provided.
• The registration process was not burdened.
• The client was able to launch commercialisation according to the planned schedule with no delay.

✓ USDA satisfied ✓ No delay to commercialisation ✓ Solution found where it seemed impossible

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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