Legal Representation & Regulatory Strategy for Clinical and Commercial Success

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

Download Corporate Brochure

Contact us to find out more!

Contact Us

Your data will be stored to provide you with information on our services and products. You may unsubscribe at any time. Please refer to our privacy policy for more information on how we store your data and how to unsubscribe.

The latest from Lumis Content Hub

A Vigilant Ally – How Authorised Representatives Support Vigilance Activities

Surgical instruments in an operating theatre
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

Map of Europe centred around southern Germany
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

Surgical instruments in an operating theatre
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

Map of Europe centred around southern Germany
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