What makes us unique

Regulation is not something to endure or tick off a checklist. When properly understood and anticipated, it protects, structures and opens doors. This conviction led Sandra Dejean to found One Health Compliance in 2017 and it guides every mission. This is what defines our approach:

  1. 1.

    A dual human–animal expertise

    One Health Compliance simultaneously masters the regulatory requirements for medical devices and in vitro diagnostics in both human and veterinary medicine. This cross-expertise opens opportunities that few companies have yet explored: transposing an innovation from the veterinary field to human health – or vice versa – while anticipating all regulatory and clinical impacts from the outset.

    • 30% of supported projects involve animal health

    • 100+ countries mapped as part of a mission for an international federation

    • Ref. Animal Health Europe & Health for Animals

  2. 2.

    An integrated strategic vision

    Beyond compliance, we act as a strategic partner in service of your business objectives. Our expertise integrates directly with the challenges of medical marketing, R&D and innovation so that regulation becomes a project accelerator, not a friction point.

    • 25% international clients

    • 32 countries covered in a single regulatory strategy project

  3. 3.

    Resolving uncertainties, in short timeframes

    Regulatory grey areas, borderline products, gaps requiring correction before an audit, urgent non-conformities: we specialise in the rapid identification of concrete and achievable solutions whether acting fast or getting ahead of the curve. Where uncertainty blocks, we bring clarity and an action plan within days when the situation demands it.

    • 100% of responses to authorities accepted

    • 20 years of field problem-solving experience

To go further

  • Case studies One Health In vitro diagnostics Strategy

    September 16, 2026

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

    Read more
  • Case studies Human health In vitro diagnostic International

    September 16, 2026

    IVDR Gap Analysis for a US Manufacturer Preparing Its Transition to the European Market

    Read more
  • September 1, 2026

    Expertise Human Health Borderline Product

    Cosmetic or Medical Device for Compromised Skin? Why an Early Clinico-Regulatory Strategic Analysis Makes the Difference

    Read more