We support you as your Legal Representative in Europe according to the EU Clinical Trial Regulation 536/2014 and the former EU Clinical Trial Directive 2001/20/EC Art. 19 (1) and in Switzerland following the Clinical Trials Ordinance.
We act as your Data Representative in accordance with the European General Data Protection Regulation (GDPR) EU 2016/679, if you are a non-European company conducting clinical trials in Europe.
Our experts have decades of experience in medical device and pharmaceutical regulatory affairs. We can help you navigate the complex regulations to expedite approvals, reduce costs, and optimise product development.
We implement specific CRO/vendor management oversight and governance strategies and processes to ensure adherence to contract and agreed budget, timelines and quality of your projects.
We provide proactive, risk-based oversight management systems to effectively manage your clinical trial performance, in compliance with relevant ICH-GCP guidelines and ISO standards.
Lumis International – Your clinical gateway to Europe
Lumis International specialises in providing legal representation for clinical trials, for non-European small to mid-sizedbio-pharmaceutical and medical device companies around the globe. We are headquartered in Germany. Find out more
Lumis Life Science Consulting – Your partner for clinical oversight
Our goal is to optimise your drug development process and clinical trials performance using a unique holistic approach from vendor selection to clinical trial oversight management. We act on behalf of our sponsors. Find out more
Contact our experts to find out more!
We look forward to helping you accelerate your clinical development!
-Are you a non-EU medical device manufacturer? If so, Lumis could be your gateway into Europe via our new authorised representative service.
In accordance with Article 11 (1) of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), any manufacturer not established within an EU Member State must designate an Authorized Representative to market their devices within the EU. …
-Outsourcing clinical trials has become an increasingly prevalent trend not only in the pharmaceutical industry but also increasingly at small to midsize biotech and medical device companies. As the complexity of drug development and regulatory requirements continue to grow, companies are turning to specialized external partners to conduct clinical trials more efficiently and cost-effectively. …
-This webinar is divided into several sections, either focusing on different aspects of orphan designation (OD) in key global markets or rare disease trials. The goal is to provide attendees with a comprehensive understanding of the benefits, application processes, and strategic implications of securing orphan designations globally. …