Lumis International
Lumis International provides specialized legal representation and consulting services for small to mid-sized biopharma and medical device companies conducting clinical trials worldwide. With over 20 years of expertise, Lumis accelerates drug development and clinical trials through tailored strategies, analytics, and solutions, ensuring reduced time-to-market, realistic budgets, and high-quality standards. The company supports market entry into Europe, UK, and Switzerland, offering services such as regulatory consulting, clinical trial management, and legal representation, with a focus on compliance, efficiency, and strategic partnership.
Industries
Nr. of Employees
small (1-50)
Lumis International
Products
Clinical Trial
Comprehensive clinical trial management, CRO management, and clinical trial oversight services ensuring seamless clinical operations, data integrity, quality, and patient safety for biotech and pharmaceutical companies.
Clinical Trial Legal Representation Services
Lumis acts as your legal representative in the EU, UK, and Switzerland for clinical trials, handling legal proceedings and ensuring compliance with regional regulations.
Authorized Representative
An authorized representative service enabling non-EU medical device manufacturers to market their devices within the EU in accordance with Article 11 (1) of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Authorized Representative Medical Devices
Authorized Representative (EC-Rep) services for non-EU medical device manufacturers to enter and comply with EU MDR and IVDR regulations.
Global Representation - Medical Devices
Global representation and international registration services acting as an in-country or authorized representative across 18 key markets including the EU, UK, US, Latin America, and Asia-Pacific regions.
Clinical Quality Management as a Service
Customized clinical quality management systems (QMS), audit services, and regulatory compliance support tailored for small and medium-sized biopharmaceutical and medical device companies.
Clinical Trial
Comprehensive clinical trial management, CRO management, and clinical trial oversight services ensuring seamless clinical operations, data integrity, quality, and patient safety for biotech and pharmaceutical companies.
Clinical Trial Legal Representation Services
Lumis acts as your legal representative in the EU, UK, and Switzerland for clinical trials, handling legal proceedings and ensuring compliance with regional regulations.
Authorized Representative
An authorized representative service enabling non-EU medical device manufacturers to market their devices within the EU in accordance with Article 11 (1) of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Authorized Representative Medical Devices
Authorized Representative (EC-Rep) services for non-EU medical device manufacturers to enter and comply with EU MDR and IVDR regulations.
Global Representation - Medical Devices
Global representation and international registration services acting as an in-country or authorized representative across 18 key markets including the EU, UK, US, Latin America, and Asia-Pacific regions.
Clinical Quality Management as a Service
Customized clinical quality management systems (QMS), audit services, and regulatory compliance support tailored for small and medium-sized biopharmaceutical and medical device companies.
Services
Act as the legal representative for sponsors without local establishment, handle legal proceedings, support CTR/CTIS compliance and assist with EMA SME recognition.
Provide full EC‑REP mandate services including due diligence, technical‑file review, EUDAMED compliance, vigilance reporting, regulatory communication and documentation archiving.
Act as GDPR/UK‑GDPR representative, manage data protection communications, oversee data processing in trials and advise on cross‑border transfers.
Sponsor oversight, project management, KPI/KRI implementation, monitoring strategy, risk management and resource provision to support outsourced clinical programs.
Regulatory strategy, CE‑marking support, clinical evaluation and post‑market consulting including submissions to competent authorities and notified bodies.
Implement and maintain clinical quality management systems to ensure inspection readiness and ongoing compliance with GCP and device clinical standards.
Act as the legal representative for sponsors without local establishment, handle legal proceedings, support CTR/CTIS compliance and assist with EMA SME recognition.
Provide full EC‑REP mandate services including due diligence, technical‑file review, EUDAMED compliance, vigilance reporting, regulatory communication and documentation archiving.
Act as GDPR/UK‑GDPR representative, manage data protection communications, oversee data processing in trials and advise on cross‑border transfers.
Sponsor oversight, project management, KPI/KRI implementation, monitoring strategy, risk management and resource provision to support outsourced clinical programs.
Regulatory strategy, CE‑marking support, clinical evaluation and post‑market consulting including submissions to competent authorities and notified bodies.
Implement and maintain clinical quality management systems to ensure inspection readiness and ongoing compliance with GCP and device clinical standards.
Expertise Areas
- Regulatory compliance for EU/UK/Swiss clinical trials (CTR/CTIS, Clinical Trial Directive/Ordinance)
- Medical device regulatory strategy and EC‑REP services (MDR/IVDR, EUDAMED)
- Clinical trial management and sponsor oversight (ICH‑GCP aligned)
- CRO/vendor selection, contracting and governance
Key Technologies
- Clinical Trials Information System (CTIS)
- EUDAMED registry and device registration systems
- Electronic consent (eConsent)
- Electronic clinical outcome assessments (eCOA)
News & Updates
Join us at the event. [Details and registration](https://www.swiss-medtech.ch/en/swissmedtechday)
Join us at the event. [Details and registration](https://biospain2025.org/)
Join us at the event. [Details and registration](https://www.cphi.com/europe/)
Join us at the event. [Details and registration](https://www.thepbcgroup.com/cog-europe)
Join us at the event. [Details and registration](https://www.medica.de/)
Join us at the event. [Details and registration](https://www.swiss-medtech.ch/en/swissmedtechday)
Join us at the event. [Details and registration](https://biospain2025.org/)
Join us at the event. [Details and registration](https://www.cphi.com/europe/)
Join us at the event. [Details and registration](https://www.thepbcgroup.com/cog-europe)
Join us at the event. [Details and registration](https://www.medica.de/)