Lumis International GmbH
Lumis International provides specialized legal representation and consulting for biopharma and medical device companies navigating EU, UK, and Swiss markets. They offer services like EU legal representation for clinical trials and authorized representation for medical devices, ensuring compliance wi
Lumis International specializes in providing expert legal representation and consulting services tailored for small to mid-sized biopharmaceutical and medical device companies. Their core mission is to empower these companies to successfully enter and navigate complex markets in the EU, UK, and Switzerland. Lumis facilitates international clinical projects by offering specialized strategies, analytics, and solutions designed to accelerate time-to-market and maintain high-quality standards, all while managing realistic budgets. Key services include acting as an EU legal representative for clinical trials, enabling companies to conduct trials in Europe without establishing a local entity. They also serve as an EU authorized representative for approved medical device products. Furthermore, Lumis offers comprehensive support for GDPR Article 27 data representation, medical device regulatory consulting, pharmaceutical and biotechnology regulatory consulting, clinical quality management, and clinical trial management and oversight services. With over 20 years of experience, Lumis International leverages its deep expertise to manage international clinical projects effectively. They are committed to helping clients overcome regulatory challenges and achieve their market entry goals efficiently and compliantly.
About
**Who they are**
Lumis International GmbH is a specialized provider of legal representation and consulting services, focusing on companies in the biopharma and medical device sectors. They assist clients in navigating the complex regulatory landscapes of the EU, UK, and Swiss markets.
**Expertise & scope**
* EU legal representation for clinical trials
* Authorized representation for medical devices
* Data representation for GDPR Article 27 compliance
* Regulatory consulting and services for medical devices
* Regulatory consulting and services for pharmaceuticals and biotechnology
* Clinical quality management
* Clinical trial management and oversight
**Reputation / proof points**
* Offers services related to GDPR Article 27 data representation.
Lumis International GmbH is a specialized provider of legal representation and consulting services, focusing on companies in the biopharma and medical device sectors. They assist clients in navigating the complex regulatory landscapes of the EU, UK, and Swiss markets.
**Expertise & scope**
* EU legal representation for clinical trials
* Authorized representation for medical devices
* Data representation for GDPR Article 27 compliance
* Regulatory consulting and services for medical devices
* Regulatory consulting and services for pharmaceuticals and biotechnology
* Clinical quality management
* Clinical trial management and oversight
**Reputation / proof points**
* Offers services related to GDPR Article 27 data representation.
Additional information
Lumis International GmbH focuses on providing essential regulatory support for life sciences companies. Their services are designed to ensure compliance with key regulations, particularly for medical devices and clinical trials operating within European markets. Buyers engaging Lumis International can expect a structured approach to representation and consulting, aimed at facilitating market access and adherence to legal requirements. The company emphasizes data privacy and representation, aligning with GDPR mandates.
Key Highlights
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Provides EU legal representation for clinical trials.
Source
“Legal representative clinical trials”
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Offers authorized representation for medical devices.
Source
“Authorized representative medical devices”
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Specializes in data representation for GDPR Article 27.
Source
“Data representation GDPR article 27”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Biopharma companies seeking EU clinical trial representation
- Medical device manufacturers requiring authorized representation in the EU
- Companies needing GDPR Article 27 representative services
How engagement typically works
- Specialized legal representation
- Regulatory consulting and services
Typical deliverables
- EU legal representation documentation
- Authorized representative appointments
- GDPR Article 27 compliance support
- Regulatory strategy and guidance
Good to know
- Best when operating within or seeking entry into EU, UK, and Swiss markets for biopharma and medical device sectors.
HQ:
Berlin, DE
Languages:
English
Timezones:
UTC+1, UTC+2
Status:
listed
Services & Capabilities
GDPR Article 27 EU/UK Representative
Coverage:
EU, UK, Switzerland
Languages:
English
Pricing Basis:
custom
Breach Notification SLA:
Custom
Regulator Comms Handling:
Respond with client approval
Additional gdpr_art27_rep Details
Coverage Details
EU, UK, and Swiss markets.
Onboarding Steps
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