Representing your medical innovation.
Empowering your product development.
At Lumis, we provide specialized legal representation and consulting services for small to mid-sized biopharmaceutical and medical device companies worldwide.
Lumis is your gateway to Europe. We empower the development of your drug or medical device with tailored strategies, analytics and solutions, ensuring reduced time-to-market with realistic budgets and the highest quality standards.
Partnering with Lumis gives you access to over 20 years of comprehensive expertise in consulting and managing international drug and medical device 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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Legal representative clinical trials
Your EU legal representative managing all relevant regulations
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Authorized representative medical devices
Your EU authorized representative for approved medical device products
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Data representation GDPR article 27
Your EU data representative aligned with relevant privacy regulations
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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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Medical device regulatory consulting & services
Ensuring regulatory compliance with medical devices
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Pharmaceutical & biotechnology regulatory consulting & services
Safeguard regulatory compliance in biopharmaceutical development
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Clinical quality management as a service
Implementing quality management solutions that ease inspection
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Clinical trial management & oversight services
Facilitate outsourcing and management of clinical trials
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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 Activities Read 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 Partner Read more
Webinar: How to devise a global orphan designation strategy
Topic:
Pharmaceutical & biotechnology regulatory consulting & services
Developing a winning regulatory strategy for Orphan Designation across the EU, USA and APAC.
Webinar: How to devise a global orphan designation strategy Read more