Empowering Biopharma & MedTech Companies to Enter and Navigate EU, UK and Swiss Markets

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At Lumis, we provide specialized legal representation and consulting services for small to mid-sized biopharma and medical device companies conducting clinical trials worldwide.

We accelerate your drug development and clinical trials with tailored strategies, analytics and solutions, ensuring reduced time-to-market and realistic budgets while maintaining the highest quality standards.

Partnering with Lumis gives you access to over 20 years of comprehensive expertise in consulting and managing international clinical projects.

More about Lumis

  • Since 2013

    Trusted for Clinical &
    Regulatory Services

  • 100+

    Biopharma &
    Medical Device Clients

  • 250+

    Projects Completed

  • 88%

    Small to Medium-
    Sized Clients

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Contact us to find out more!

Heike Schön
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The latest from Lumis Content Hub

Integrating Service Provider Management and Risk‑Based Quality Systems under ICH E6(R3)

A graphic showing a hand with a diagram above it of a stylised globe with groups of people overlaid on it
Topic: Clinical trial management & oversight services

Delegating with oversight empowers responsible outcomes. By integrating rigorous service provider management with a cross‑functional, risk‑based quality management system, sponsors can fulfil their oversight duties in alignment with ICH E6(R3). This article outlines practical “to‑dos” for ensuring compliant trial conduct, participant safety, and data integrity.

Integrating Service Provider Management and Risk‑Based Quality Systems under ICH E6(R3)Read more

Navigating the Labyrinth: The CE-Marking Challenges for AiMD and SaMD in the EU

Illustration for AiMD and SaMD, showing a computer screen, a brain, a mobile device, a syringe and other elements linking technology to medical interests
Topic: Medical device regulatory consulting & services

The European Union’s Medical Device Regulation and the new Artificial Intelligence Act introduced a seismic shift for medical device companies. For developers of Software as a Medical Device (SaMD) and, specifically, Artificial Intelligence Medical Devices (AiMD), obtaining the coveted CE mark has become significantly more complex.

Navigating the Labyrinth: The CE-Marking Challenges for AiMD and SaMD in the EURead more

Integrating Service Provider Management and Risk‑Based Quality Systems under ICH E6(R3)

A graphic showing a hand with a diagram above it of a stylised globe with groups of people overlaid on it
Topic: Clinical trial management & oversight services

Delegating with oversight empowers responsible outcomes. By integrating rigorous service provider management with a cross‑functional, risk‑based quality management system, sponsors can fulfil their oversight duties in alignment with ICH E6(R3). This article outlines practical “to‑dos” for ensuring compliant trial conduct, participant safety, and data integrity.

Integrating Service Provider Management and Risk‑Based Quality Systems under ICH E6(R3)Read more

Navigating the Labyrinth: The CE-Marking Challenges for AiMD and SaMD in the EU

Illustration for AiMD and SaMD, showing a computer screen, a brain, a mobile device, a syringe and other elements linking technology to medical interests
Topic: Medical device regulatory consulting & services

The European Union’s Medical Device Regulation and the new Artificial Intelligence Act introduced a seismic shift for medical device companies. For developers of Software as a Medical Device (SaMD) and, specifically, Artificial Intelligence Medical Devices (AiMD), obtaining the coveted CE mark has become significantly more complex.

Navigating the Labyrinth: The CE-Marking Challenges for AiMD and SaMD in the EURead more