Looking for simplified access to the EU Market?

Then it is critical to ensure your compliance is up to speed.

Accessing the European biopharma and medical device market can be challenging as well as costly.

Failure to comply with the EU regulations can mean your product being denied access to the lucrative EU market – an expensive waste of any company’s time.

Furthermore the new 2022 clinical EU trial regulations will present fresh challenges for sponsors to manage.

At Lumis international, we understand all of this.

Since 2013 we have been helping global biopharmaceutical and medical device companies access the European market more quickly, efficiently and cost-effectively.

With offices in Switzerland and the UK, we have a wide network of experts with in-depth knowledge of the EU regulatory landscape; plus the Lumis UK office supports local clients in data representation.

Flexibility and empathy are core to the Lumis brand. We go the extra mile supporting our clients.

Work with us to achieve:

  • Peace of mind knowing your trial is fully compliant

  • Shorter time to market for innovative products

  • Cost-savings by utilising our in-depth knowledge

  • Expertise in partnership working across the whole clinical trial team

How we can help:

  • Legal
    Representation

  • Orphan Drug
    Designation

  • SME
    Status

  • GDPR Data
    Representation

'Refreshingly straightforward'

“Lumis International GmbH have been invaluable in helping us with our legal and data privacy representation needs in the EU. Working in partnership with them has been refreshingly straight-forward.

Since 2015, Lumis have been my ‘go to’ European partner as Legal Representative.”

Patrick McNamara, Vice President,
Clinical Operations at Blueprint Medicines

A team with far-reaching expertise

Heike Schön, Managing Director, has more than 25 years’ experience in senior management positions in clinical research and has a profound understanding of the different business models of sponsors and service provider.

Alongside Heike on the Management Board, sits Myrthe Trompert, a renowned lawyer in the clinical research industry and Prof. Kurt Miller, an entrepeneur by passion and former Professor of Urology and Department Chair at the Benjamin Franklin Medical Center’s Department of Urology in Berlin.

Sathya Ram is an experienced Project Assistant who ensures the smooth running of projects and provides day to day support to our clients.

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Webinar: 27 January 2022

Patients First! Decentralization – The (new) Clinical Trial Paradigm

Paradigm shift