Theragenesis

TheraGenesis GmbH is a long-established, privately-held European CRO with deep expertise in piloting the regulatory and clinical development pathway for innovative medical devices, diagnostics, and advanced therapy medicinal products (ATMPs). Unlike a biotech developing its own therapeutics, TheraGenesis operates as a service provider, leveraging decades of experience to guide client products through the complex European regulatory landscape. The company's value proposition lies in its broad therapeutic experience, geographic reach across Europe, and the seasoned leadership of its Managing Director, Erik Hesse, who is actively involved in professional regulatory societies.

Integrated regulatory and clinical development service platform for medical devices, IVDs, and Advanced Therapy Medicinal Products (ATMPs), including technology assessment, conformity management, clinical strategy, and Authorized Representative services.

TheraGenesis competes with a wide range of players, from large global CROs (like IQVIA, Parexel) with full-service offerings to small boutique regulatory consultancies. Its differentiation lies in its long-standing European focus, specific expertise in devices and ATMPs, and the hands-on, senior-level involvement of its founder.