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
Berlin, Berlin, Germany, Europe
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/)