Clemann Group

What Clemann Group does

Clemann Group is a Dijon, France-based private professional services firm (SAS, R.C.S. Dijon 789 676 087) that operates as a multidisciplinary services integrator for pharmaceutical, biotech, and medtech developers. Founded by Christophe Clément (CEO, 22 years CRO/biotech/clinical operations experience) and Fabrice Heitzmann (General Manager, 20 years pharma procurement and strategic planning), the firm aggregates legal counseling, IP management, CMC and pharmaceutical affairs, regulatory positioning, pre-clinical and clinical development planning, licensing negotiation, quality assurance, and pharmaceutical operations support under a single engagement model. Its stated mission is to make senior pharma expertise accessible to startups and innovators from discovery through marketization.

The firm monetizes through project- and retainer-based professional services fees rather than technology licensing, with three operational pillars: Innovate (IP lifecycle), Develop (regulatory, CMC, pre-clinical/clinical planning), and Create Value (entrepreneurial coaching and strategic development). A differentiated offering is EU Legal Representation for non-EEA sponsors conducting clinical trials under EU Directive 2001/20/EC, plus GDPR legal representation across all EU member states. The firm holds French regulatory credentials including ANSM medicines broker registration (CMED2017-002), JEI (Jeune Entreprise Innovante) status, and a Crédit Impôt Recherche (CIR) agreement, which together create privileged access to pharmaceutical commercial deals and French R&D tax benefits.

Customer acquisition is sales-led and referral-driven, leveraging the founders' 20-year professional networks across CROs, biotech, pharma, and health authorities. The firm serves two primary segments — non-EU pharma/biotech sponsors needing an EEA legal representative, and young innovative life sciences companies lacking in-house multidisciplinary expertise — with a secondary segment of GDPR compliance clients. In March 2026, Clemann Group divested its blood-brain barrier delivery technology and CNS/Alzheimer's drug assets to Lunai Bioworks (NASDAQ:LNAI) for $20 million in Series B Convertible Preferred shares, retaining the services platform as its core operating asset.

Name

Clemann Group

Legal name

Clemann Group

Website

https://clemann-group.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

Clemann Group is a French pharma/biotech/medtech services integrator offering EU legal representation, GDPR compliance, and multidisciplinary development support (regulatory, CMC, IP, pre-clinical/clinical) for non-EU sponsors and early-stage life sciences innovators from its Dijon headquarters.

Ownership category

akta.pro rank

Product category

Pharmaceutical Development Services

NAICS

Management Consulting Services (54161), Offices of Lawyers (541110)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Legal Services (8111)

akta.pro primary industry

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

akta.pro secondary industries

Clinical CROs (Phase I–IV) (HLAGAAAA), Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC), Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM)

Keywords

• Pharmaceutical development services
• Clinical trial legal representation
• Regulatory affairs consulting
• EU GDPR compliance services
• Medicines broker services

Headquarters

HQ city

Dijon

HQ country

France

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales

Revenue model

1. Pharma Development Services: Clemann Group generates revenue by providing integrated consulting and representation services to pharma, biotech, and medtech developers. Services include legal representation in the EU, regulatory affairs, CMC, pre-clinical and clinical development planning, IP management, licensing negotiation, quality insurance, and pharmaceutical operations. The model is service-fee based, likely project or retainer engagements.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

Clemann Group provides integrated pharmaceutical, biotech, and medtech development services to innovative founders, acting as a services integrator across legal counseling, IP management, CMC and pharmaceutical affairs, regulatory positioning, pre-clinical and clinical development, licensing-out, pharmaceutical operations, and quality assurance. The firm also serves as an EU legal representative for non-EEA sponsors conducting clinical trials in the EU under EU Directive 2001/20/EC and as a GDPR legal representative/DPO coordinator across all EU member states, and is registered as an ANSM medicines broker (CMED2017-002).

Product overview

Clemann Group operates as a unified services platform for pharmaceutical, biotech, and medtech development. The platform integrates three core service pillars—Innovate (IP lifecycle management), Develop (regulatory, CMC, preclinical and clinical plans), and Create Value (entrepreneurial coaching and optimization)—alongside specialized EU Legal Representation and GDPR compliance services. The EU Legal Representation and GDPR Legal Representation modules form essential compliance pathways for non-EU sponsors conducting clinical trials or processing EU resident data, while the ANSM Medicines Broker Services enables commercial pharmaceutical transactions. All services are delivered through a collaborative, multidisciplinary approach drawing on 20 years of pharma industry expertise.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharma Development Services Platform Integrated multidisciplinary services platform supporting pharma, biotech, and medtech developers across the full development lifecycle from discovery through marketization, combining IP management, regulatory affairs, CMC, pre-clinical and clinical development planning, licensing-out negotiations, pharmaceutical operations, and quality assurance. Target users are early-stage biotech, pharma, and medtech startups and their founders.
• EU Legal Representation Services Legal representation services for sponsors conducting clinical trials or medical device investigations in the European Union, ensuring compliance with EU Commission directives and health authority requirements. Required under EU Clinical Trials Directive 2001/20/EC and Medical Device Directive 93/42 EEC for non-EU sponsors needing an EEA-registered legal representative to obtain Health Authority approvals.
• GDPR Legal Representation Data protection compliance representation services for GDPR across all EU member states, including Data Protection Officer (DPO) coordination and local citizen communication. Applicable to EU-based and non-EU companies that process EU resident personal data and require an EU-based GDPR representative.
• ANSM Medicines Broker Services Official medicines broker services registered with ANSM (Agence nationale de sécurité du médicament et des produits de santé) under approval number CMED2017-002, enabling support to partners in pharmaceutical product commercial deals.

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

One partnership is on record.

• Lunai Bioworks, Inc. (NASDAQ:LNAI)majorTechnology or Integration · 26 March 2026In March 2026, Clemann Group sold its blood-brain barrier (BBB) delivery technology and CNS/Alzheimer's drug assets to Lunai Bioworks for $20 million. The transaction was structured as Series B Convertible Preferred shares at a fixed $1.50 conversion price with a 19.9% beneficial ownership cap. This strategic sale transferred Clemann Group's CNS drug delivery platform and Alzheimer's assets to Lunai, strengthening the latter's central nervous system pipeline.

Scale indicators2 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Parexel International: Global CRO providing clinical research, regulatory consulting, and commercialization services. Comparable to Clemann's clinical development and regulatory positioning offerings but at vastly greater scale and breadth.
• IQVIA: World's largest CRO offering clinical development, regulatory affairs, real-world evidence, and consulting across the full pharma lifecycle. A broad incumbent against which Clemann competes on integrated service depth and European SME-segment focus.
• Charles River Laboratories: Major preclinical and clinical CRO with integrated regulatory support and manufacturing services. Overlaps with Clemann's preclinical/clinical development and CMC offerings as part of a much broader portfolio.
• Medpace: Mid-sized CRO offering full-service clinical development and regulatory services for biotech and pharma. Comparable to Clemann on clinical development focus, though at materially greater scale and geographic reach.

Direct peers

• PharmaLex (now part of Cencora): Specialized regulatory affairs, pharmacovigilance, and compliance consulting for life sciences companies. Highly comparable to Clemann in offering multidisciplinary regulatory and development support across Europe and globally.
• CATS Consultants (ClinBAY): European clinical and regulatory consulting services provider for pharma and biotech. Direct peer to Clemann given similar boutique-style offering around clinical operations and regulatory support for smaller life sciences developers.
• Voisin Consulting Life Sciences: Europe-based regulatory affairs and product development consultancy serving pharma, biotech, and medtech. Direct comparable to Clemann Group with similar integrated service model for small-to-mid sponsors needing regulatory, CMC, and clinical development expertise.
• EUDRAC: German regulatory consulting firm specializing in EU regulatory affairs for drugs, biologics, and medical devices. Directly comparable niche positioning to Clemann, serving biotech and medtech developers needing EU regulatory expertise.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/clemann-group

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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

M&A

Investments1 record

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

Frequently asked questions about Clemann Group