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 biopharma and medical device companies. 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
* Medical device regulatory consulting and services
* Pharmaceutical and biotechnology regulatory consulting and services
* Clinical quality management as a service
* Clinical trial management and oversight services
**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 biopharma and medical device companies. 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
* Medical device regulatory consulting and services
* Pharmaceutical and biotechnology regulatory consulting and services
* Clinical quality management as a service
* Clinical trial management and oversight services
**Reputation / proof points**
* Offers services related to GDPR Article 27 data representation.
Additional information
Lumis International GmbH focuses on ensuring compliance for companies operating within the biopharmaceutical and medical device sectors. Their services are designed to address specific regulatory requirements, such as acting as an EU legal representative for clinical trials and an authorized representative for medical devices. They also provide data representation services specifically for GDPR Article 27, indicating a targeted approach to data protection compliance for relevant entities. Clients can expect support in navigating market access and ongoing regulatory obligations in key regions including the EU, UK, and Switzerland.
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
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Provides specialized legal representation and consulting for biopharma and medical device companies.
Source
“Lumis International provides specialized legal representation and consulting for biopharma and medical device companies”
Buyer Snapshot
Best for
- Biopharma companies needing EU clinical trial representation
- Medical device manufacturers requiring authorized representation
- Companies needing GDPR Article 27 data representation
How engagement typically works
- Specialized legal representation
- Regulatory consulting services
Typical deliverables
- EU legal representative appointment
- Authorized representative appointment
- GDPR Article 27 data representation
- Regulatory consulting reports
Good to know
- Best when targeting EU, UK, and Swiss markets
HQ:
Berlin, DE
Languages:
English
Timezones:
UTC+1, UTC+2
Claim status:
Listed
Services & Capabilities
GDPR Article 27 EU/UK Representative
Coverage:
GDPR Article 27 Representative
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., and Swiss markets
Onboarding Steps
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