Lumis International

What Lumis International does

Lumis International GmbH is a Berlin-headquartered regulatory affairs and clinical research consultancy founded in 2013 that provides specialized legal representation and regulatory services to small and mid-sized biopharmaceutical and medical device companies. Its core offering is serving as the mandatory EU legal representative (EU CTR 536/2014), authorized representative (EC-REP under EU MDR/IVDR), and GDPR Article 27 data representative for non-EU sponsors and manufacturers that lack a local European entity. Beyond these regulatory mandates, Lumis provides consulting on CE marking, clinical evaluation reports, orphan designation, scientific advice, clinical trial oversight, CRO and vendor management, and quality management as a service.

The firm has built its presence around eight service lines — legal representation for clinical trials, authorized representation for medical devices, GDPR data representation, medical device regulatory consulting, pharmaceutical and biotechnology regulatory consulting, clinical quality management as a service, clinical trial management and oversight, and global in-country representation across 18 markets on five continents. Service delivery is consultant-led using industry-standard document management and regulatory submission tooling; no proprietary technology platform is operated. Lumis invests in thought leadership across emerging topics including ICH E6(R3), EU MDR/IVDR, the EU AI Act for SaMD/AiMD, decentralized clinical trials, and CTR transitions.

Commercially, Lumis operates as a project-and-retainer professional services firm with multi-year engagements billed directly to clients. Go-to-market is sales-led and event-driven, anchored by content marketing (blog, webinars, case studies, gated downloads such as a CE Marking Scorecard), conference speaking (including ACRP and Med-Cannabis), and a network of CRO, distributor, and import partners that generate referrals internationally. As of disclosed data, the company has served more than 100 biopharma and medtech clients (88% SMEs) and completed more than 250 projects across the EU, UK, and Switzerland. Lumis is privately held by three founding shareholders, with no institutional investors or parent company, and was deliberately grown organically without external funding.

Name

Lumis International

Legal name

Lumis International GmbH

Website

https://lumisinternational.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

Lumis International is a Berlin-based regulatory affairs consultancy that serves as EU legal representative, EC-REP, and GDPR data representative for small and mid-sized biopharma and medical device companies lacking a European presence, complemented by regulatory strategy, clinical trial oversight, and in-country representation across 18 global markets.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Scientific Research and Development Services (5417), Professional, Scientific, and Technical Services (54), All Other Professional, Scientific, and Technical Services (54199)

SIC

Services-Business Services, Nec (7389), Services-Commercial Physical & Biological Research (8731), Services-Misc Health & Allied Services, Nec (8090)

akta.pro industry

PRIMARYHLAGAKAA

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

SECONDARYHLAGAAAG

Medical Writing & Regulatory Submission Support CROs

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAKAC

Regulatory Operations & Publishing (eCTD, RIM, Submission Management)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

SECONDARYHLAGAJAB

Electronic Lab Notebooks (ELN)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Life Science Software & Informatics (LIMS/ELN/Bioinformatics)

Keywords

• Regulatory affairs consulting
• Clinical trial management
• EU legal representation
• Medical device compliance
• Biopharmaceutical consulting

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Others

Revenue model

1. Regulatory Consulting Services: Fee-for-service consulting engagements covering EU MDR/IVDR regulatory strategy, CE marking support, clinical evaluation reports (CER), technical documentation, and regulatory submissions for medical devices and biopharmaceutical products.
2. Legal Representation Services: Ongoing retainer and project-based fees for serving as EU legal representative (EU CTR 536/2014), authorized representative (EC-REP under MDR/IVDR), and data representative (GDPR Article 27) for non-EU manufacturers and sponsors.
3. Clinical Trial Management & Oversight Services: Project-based and retainer engagements for managing and overseeing clinical trials, including CRO/vendor management, risk-based quality management, KPI oversight, and ICH E6(R3) GCP compliance support.
4. In-Country Representative Services: Ongoing representative services across 18 global markets (EU, UK, Switzerland, North America, South America, Australia, Asia) enabling medical device manufacturers to fulfill local regulatory representation mandates for market entry and post-market compliance.

Pricing tiers

Go-to-market motion3 records

Distribution channels2 records

Marketing channels8 records

Core offering

Lumis International is a regulatory affairs and clinical research consultancy that provides specialized legal representation and consulting services for small to mid-sized biopharma and medical device companies. Its core offerings include EU legal representation for clinical trials, authorized representative (EC-REP) services under MDR/IVDR, GDPR Article 27 data representation, regulatory consulting for medical device CE marking and biopharmaceutical drug development, clinical quality management, and clinical trial oversight. Services are delivered through direct consulting engagements and enable non-EU companies to access European, Swiss, and UK markets without establishing a local subsidiary.

Product overview

Lumis International is a regulatory consulting services company (not a software platform) offering specialized legal representation and consulting services for small to mid-sized biopharma and medical device companies. The company provides seven core service lines: (1) Legal Representative Clinical Trials for EU/EEA regulatory compliance, (2) Authorized Representative Medical Devices (EC-REP) for medical device market access, (3) Data Representation GDPR Article 27 for privacy compliance, (4) Medical Device Regulatory Consulting & Services including CE marking support for SaMD/AiMD, (5) Pharmaceutical & Biotechnology Regulatory Consulting & Services including orphan designations and CTR transitions, (6) Clinical Quality Management as a Service, and (7) Clinical Trial Management & Oversight Services including CRO management and vendor oversight. The company also offers Global In-Country Representation Services covering 18 markets across 5 continents. Services are delivered through direct consulting engagements rather than a software product.

Differentiator

Problem solved

Functional benefit

Products and services

• Legal Representative Clinical Trials

Quantifiable outcome

• Over 20 years of combined expertise in consulting and managing international clinical projects
• +3 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Seven partnerships are on record, tiered supporting and core.

• Global Pharma SolutionssupportingStrategic or Co-development Partner · 11 July 2024Global Pharma Solutions collaborated with Lumis on a webinar covering global orphan designation strategy across the EU, USA, and APAC regions. Team members Margaret Jenkins, John Oakley, Helen Sutton, and Tina Soulis from Global Pharma Solutions co-presented with Lumis experts Heike Schön and Liam Spencer.
• BlueCloud TVsupportingGTM or Marketing Partner · 16 June 2023BlueCloud TV is a media and networking platform for the life sciences industry that conducted an interview with Lumis CEO Heike Schön, providing a marketing and visibility platform for Lumis's expertise and services.
• Signant HealthsupportingTechnology or Integration · 27 January 2022Signant Health, a technology company specializing in eConsent, eCOA, and decentralized clinical trial platforms, co-presented a webinar with Lumis on the paradigm shift to decentralized clinical trials. Mika Lindroos from Signant Health contributed expertise on technology-enabled participant-centric clinical trial approaches.
• Salvius Legal B.V.supportingImplementation/ SI/ Consulting Partner · 17 June 2021Salvius Legal B.V. is a legal services firm specializing in life sciences and clinical trial contracting. Partner Myrthe Trompert co-presented webinars with Lumis on smart outsourcing and clinical study design, providing legal contracting expertise complementing Lumis's regulatory and operational services.
• Lumis Life Science Consulting GmbHcoreImplementation/ SI/ Consulting Partner · 10 September 2020Lumis Life Science Consulting GmbH is a related consultancy firm that co-presents webinars with Lumis International on topics such as effective vendor management in clinical trials and smart outsourcing strategies. The two organizations share team members (Christiane Juhls, Nancy Meyerson-Hess) and collaborate on educational content for the clinical research community.
• CRO Partners (unnamed)coreChannel Partner/ Reseller/ DistributorLumis has established partnerships with Contract Research Organizations (CROs) worldwide as a key channel for customer acquisition and service delivery. CROs refer clients needing legal representation services and collaborate on clinical trial management engagements. This partner network spans multiple continents and is integral to Lumis's ability to serve clients across 18 global markets.
• Distributor and Import Partners (unnamed)supportingChannel Partner/ Reseller/ DistributorLumis has partnered with distributors and importing experts across global markets to facilitate medical device market entry for clients. These partners support logistics, local market access, and regulatory compliance in markets beyond the EU, including Asia-Pacific, Latin America, and North America.

Scale indicators6 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Maetrics: Maetrics is a regulatory affairs and quality compliance consultancy focused on medical device and SaMD manufacturers navigating EU MDR/IVDR and FDA pathways. It competes directly with Lumis on EU authorized representative selection and CE marking strategy for SME clients.
• Qserve Group: Qserve Group is a Netherlands-based regulatory and quality consulting firm specializing in medical device EU MDR/IVDR compliance and Notified Body preparation. It directly competes with Lumis in the CE marking and authorized representative advisory niche for SME medtech companies.
• Emergo by UL (now UL Solutions): Emergo is one of the largest dedicated EU authorized representative and global medical device market access consultancies; acquired by UL Solutions in 2022. It competes head-on with Lumis's EC-REP and in-country representation services for non-EU manufacturers.
• Voisin Consulting Life Sciences (now Fortrea): Voisin Consulting is a regulatory affairs and clinical development consultancy for medical devices and biologics, now part of Fortrea. It competes with Lumis on EU regulatory strategy, clinical evaluation reports, and device/biotech market access consulting.
• RQM+: RQM+ is a regulatory and quality consulting firm focused on medical device and IVD companies, with EU MDR/IVDR and clinical evaluation expertise. It competes directly with Lumis in CE marking, Notified Body engagement, and post-market surveillance consulting for SMEs.
• Advena Medical: Advena Medical is a UK-based EU authorized representative and medical device regulatory consultancy serving non-EU manufacturers. It overlaps directly with Lumis's authorized representative and CE marking service lines for SME medtech clients.
• Clinipace Worldwide (now CMAX): Clinipace Worldwide is a mid-sized CRO that also provides regulatory affairs and clinical trial management services to biopharma sponsors. It overlaps with Lumis on EU clinical trial legal representation and CRO oversight for SME biotech clients.

Broad incumbents

• IQVIA: IQVIA is the world's largest CRO and life sciences services firm, offering regulatory affairs, clinical trial services, and — through the acquired Emergo business — EU authorized representative services. It is a broad incumbent competing with Lumis in regulatory consulting for biopharma and medtech.
• Medpace: Medpace is a large global CRO providing full-service clinical trial and regulatory services to biopharma. While much larger and broader than Lumis, it competes in EU clinical trial management and regulatory support for mid-sized biotech sponsors in Lumis's SME target segment.

Regional players

• Sirius Medical (regulatory consulting): Sirius Medical is a Germany-based medical device regulatory affairs consultancy offering CE marking and EU compliance support to SME manufacturers. It competes with Lumis on the same domestic (DACH) SME medtech segment.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/organization-guest/company/lumis-international-gmbh
• Xx.com/lumisintl

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Lumis International