Empowering Biopharma & MedTech Companies to Enter and Navigate EU, UK and Swiss Markets
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.
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Legal Services
Lumis Legal Representation Services offers representation for small to mid-sized biopharmaceutical and medical device companies worldwide, allowing you to conduct clinical trials in Europe, Switzerland and the UK without a local presence.
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Consulting services
Lumis Consulting Services provides comprehensive support for outsourcing and overseeing clinical trials, implementing quality management solutions, and addressing regulatory challenges in biopharmaceutical and with medical devices.
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Contact us to find out more!
The latest from Lumis Content Hub
A Vigilant Ally – How Authorised Representatives Support Vigilance Activities
Topic: Authorized representative medical devices
For medical device manufacturers outside the EU, Authorized Representatives are crucial for navigating the complexities of the MDR and IVDR. Authorised representatives provide essential support for vigilance activities and play a key role in supporting CAPA processes. Authorised representative involvement strengthens compliance and communication, allowing manufacturers to focus more on innovation whilst maintaining the highest level of safety and performance.
A Vigilant Ally – How Authorised Representatives Support Vigilance ActivitiesRead more
Beyond Compliance: Transform Your Authorized Representative into a Strategic Partner
Topic: Authorized representative medical devices
Authorised Representatives (EC-REP) can be strategic partners and not just a compliance necessity. A good EC-REP provides regulatory insights, strengthens supply chains, supports post-market activities, and offers access to expert networks. Therefore, choosing the right EC-REP is crucial for EU market success.
Beyond Compliance: Transform Your Authorized Representative into a Strategic PartnerRead more
A Vigilant Ally – How Authorised Representatives Support Vigilance Activities
Topic: Authorized representative medical devices
For medical device manufacturers outside the EU, Authorized Representatives are crucial for navigating the complexities of the MDR and IVDR. Authorised representatives provide essential support for vigilance activities and play a key role in supporting CAPA processes. Authorised representative involvement strengthens compliance and communication, allowing manufacturers to focus more on innovation whilst maintaining the highest level of safety and performance.
A Vigilant Ally – How Authorised Representatives Support Vigilance ActivitiesRead more
Beyond Compliance: Transform Your Authorized Representative into a Strategic Partner
Topic: Authorized representative medical devices
Authorised Representatives (EC-REP) can be strategic partners and not just a compliance necessity. A good EC-REP provides regulatory insights, strengthens supply chains, supports post-market activities, and offers access to expert networks. Therefore, choosing the right EC-REP is crucial for EU market success.
Beyond Compliance: Transform Your Authorized Representative into a Strategic PartnerRead more