Dr. Regenold GmbH

What Dr. Regenold GmbH does

Dr. Regenold GmbH is an independent, family-owned regulatory, clinical, and market access consultancy headquartered in Badenweiler, Germany, founded in 1994 to help life sciences companies bring pharmaceuticals, medical devices, IVDs, drug-device combination products, SaMD/digital health, ATMPs, and borderline or food/cosmetic products through development, approval, and post-market lifecycle in the EU and UK. Its core technology and delivery platform is regulanet® — an exclusive, 25-year-old curated network of independent development, regulatory, and market access experts in 90+ countries that operates under regenold-defined standards for communication, documentation, authority interaction, and regulatory writing, with a regenold project lead acting as the single accountable point of contact. The firm also holds its own Manufacturing and Importation Authorisations (MIA and IMP MIA) in Ireland via JensonR+ (Ireland) Ltd and UK Manufacturing authorisations, employing named Qualified Persons, Responsible Persons, QPPVs, and National Contact Persons in-house — enabling clients, particularly non-EU sponsors, to use regenold licences for EU/UK batch release, MAH holding, and clinical trial sponsorship without building local infrastructure.

Regenold operates directly from offices in Germany, the UK (Barnstaple and Nottingham), Ireland (Longford and Dublin), Portugal (Algés), and Switzerland, and reaches 90+ additional countries via regulanet®. Its offering is structured across dedicated service lines for pharmaceuticals, biologics/biosimilars/ATMPs, medical devices, IVDs and companion diagnostics, digital health/SaMD, combination products, borderline products, and food/cosmetics (the last via the nutracompliance.com sub-brand), supported by cross-cutting services in regulatory strategy, CMC, clinical development, scientific writing, quality/compliance, pharmacovigilance and device vigilance, market access and HTA, and due diligence.

The business model is professional services delivered on bespoke, multi-month to multi-year engagements, supplemented by recurring managed-services revenue from licensed-infrastructure roles (MAH, RP, QPPV, NCP, batch certification). Pricing is quote-based with no public rate card; engagements are initiated through an 'Arrange a Call' funnel (HubSpot and Zeeg booking) and typically scoped per workstream. The go-to-market is enterprise field sales into pharma sponsors, medical device and IVD manufacturers, digital health developers, and non-EU companies seeking EU/UK infrastructure, with the company citing 2,000+ innovators guided and 10,000+ successful product submissions across 90 countries as its commercial credibility base.

Name

Dr. Regenold GmbH

Legal name

regenold GmbH

Website

https://regenold.com

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

101–250 employees

Short description

Dr. Regenold GmbH is an independent, family-owned German regulatory, clinical, and market access consultancy, founded 1994, serving pharma, medical device, IVD, SaMD, and combination product developers across the EU/UK via direct offices in five European countries and its exclusive regulanet® expert network spanning 90+ countries.

Ownership category

akta.pro rank

Headquarters

HQ city

Badenweiler

HQ country

Germany

HQ region

Europe

Offices7 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory, clinical, and development professional services: Fee-based consulting and managed services across the full life sciences product lifecycle — preclinical, clinical, CMC, regulatory strategy, quality/compliance, pharmacovigilance, market access/HTA, post-approval lifecycle, due diligence, and strategic advisory. Engagements are typically scoped per workstream (e.g., MAA preparation, scientific advice, variations, MAH holding) and delivered as bespoke multi-month or multi-year service contracts.
2. Licensed infrastructure / named compliance roles (MAH, RP/RPi, QP, QPPV): Recurring/ongoing service revenue from acting as Marketing Authorisation Holder and providing named compliance roles (Qualified Person, Responsible Person, QPPV, National Contact Person) on the company's own MIA, IMP MIA, and WDA licences in Ireland and the UK, including batch certification for EU market supply.
3. Coordinated multi-country programme delivery via regulanet®: Programmatic revenue from coordinated global development, regulatory, and market access projects delivered through regulanet® partners in 90+ countries, with regenold as lead and single accountable point of contact — covering North America, LATAM, Europe, MENA, and Asia.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels5 records

Core offering

Dr. Regenold GmbH (regenold) is an independent regulatory, clinical development, and market access consultancy that delivers end-to-end integrated services for life sciences companies across pharmaceuticals, biologics/ATMPs, medical devices, IVDs, digital health/SaMD, drug-device combination products, borderline products, and food/cosmetics. The firm combines direct service delivery from offices in Germany, the UK, Ireland, Portugal and Switzerland with its proprietary global partner network regulanet® spanning 90+ countries, and holds its own manufacturing and importation authorisations in Ireland and the UK to act as Marketing Authorisation Holder, Qualified Person, Responsible Person, QPPV and National Contact Person on behalf of clients.

Differentiator

Problem solved

Functional benefit

Brands

• regulanet®: Exclusive international platform/network of independent development, regulatory, and market access experts covering more than 90 countries, founded in 2001.

Products and services

• Pharmaceuticals Regulatory & Development Services End-to-end integrated pharmaceutical development and regulatory services covering regulatory strategy and operations, CMC, clinical development, scientific writing, regulatory intelligence and lifecycle/variations management for innovator, generic and herbal products.
• Biologicals, Biosimilars & ATMPs Services Development, regulatory and market access support for classical biologics/vaccines, biosimilars and ATMPs, including CAT classification requests, comparability strategy, immunogenicity, potency assay design, and EU Joint Clinical Assessments under the HTA Regulation.
• Medical Devices Services MDR compliance, conformity assessment, clinical evaluation (CER), risk management (ISO 14971), human factors/usability (IEC 62366), biocompatibility (ISO 10993), PMS/PSUR, vigilance and EU Authorised Representative/PRRC services for medical device manufacturers.
• In Vitro & Companion Diagnostics Services IVDR Annex VIII classification, performance evaluation, EU Reference Laboratory consultation for Class D, IVDR Article 48 CDx consultation, and co-development of companion diagnostics with corresponding medicinal products.
• Digital Health & SaMD Services Software-as-a-Medical-Device regulatory services including MDR Rule 11 classification, IEC 62304 lifecycle, cybersecurity, AI/ML device documentation (training data governance, bias assessment, PCCP), EU AI Act conformity for high-risk AI, and BfArM DiGA fast-track support.
• Combination Products Services Integrated drug-device combination product services covering primary mode of action assessment, integral/co-packaged/ancillary classification, MDR Article 117 NB opinion, dual QMS, extractables & leachables, human factors and connected combined products.
• Borderline Products Services Product classification analysis between medicinal product, medical device, food supplement, cosmetic and biocidal frameworks; ongoing classification monitoring and structured assessments to prevent reclassification risk at submission or post-launch.
• Food & Cosmetics Services (NutraCompliance) Regulatory support for food supplements (novel food, health claims under Regulation (EU) 2015/2283, national notification) and cosmetics (Regulation (EC) No 1223/2009, CPNP notification, Product Information File, Responsible Person), delivered through the NutraCompliance brand.
• Pharmacovigilance & Device Vigilance Services EU QPPV and UK QPPV services, National Contact Person, PV System Master File, PSMF, ICSR/ADR processing, PSUR/PBRER, signal detection, RMP, and device vigilance under MDR.
• Quality & Compliance Services GMP/GDP compliance, QMS, deviation/CAPA management, document control, vendor qualification, audit and inspection readiness, and GxP auditing.
• Regulatory Compliance Roles & Legal Representation EU Authorised Representative, Person Responsible for Regulatory Compliance (PRRC), EU QPPV, UK RP/RPi, EU Sponsor/Legal Representative for clinical trials, Marketing Authorisation Holder infrastructure, and FBO/Responsible Person for cosmetics, delivered on regenold's own MIA, IMP MIA, WDA and UK Manufacturing authorisations.
• Market Access & HTA Strategy Pricing, reimbursement and HTA strategy support, including EU Joint Clinical Assessments under the HTA Regulation, country-specific reimbursement submissions and health economics.
• regulanet® Global Expert Network Regenold's proprietary global partner network connecting independent development, regulatory and market access experts across 90+ countries under common standards for communication, documentation, regulatory writing and authority interaction; coordinated by a regenold project lead for integrated multi-country delivery.

Quantifiable outcome

• Guided 2,000+ innovators from development to market access since 1994
• +5 more outcomes

Segments7 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

AI capability1 record

Feature5 records

Partnerships

Eight partnerships are on record, tiered flagship / core platform, core infrastructure vendor, supporting vendor, adjacent brand, core legal entity and operational dependency.

• regulanet® partner network (90+ countries)flagship / core platformStrategic or Co-development Partner · 1 January 2001Exclusive long-established network of independent development, regulatory, and market access experts founded by regenold in 2001 across more than 90 countries (North America, LATAM, Europe, MENA, Asia). Partners work to a common set of standards on communication, documentation, project handover, regulatory writing conventions, and authority interactions. A regenold project lead provides single accountability, integrating the right experts; alternatively, clients can be referred directly to the regulanet® partner best suited to the task.
• HubSpot Ireland Ltd.core infrastructure vendorTechnology or IntegrationEngaged as a data processor under Art. 28 GDPR. Used by regenold for (a) online appointment booking on the website (alongside Zeeg) and (b) newsletter distribution and recipient-list management (alongside Odoo). HubSpot Ireland Ltd., 2nd Floor, 30 North Wall Quay, Dublin 1, Ireland is the named provider.
• Zeeg GmbHsupporting vendorTechnology or IntegrationAppointment-booking tool used on the regenold website to allow visitors to schedule meetings with specific regenold representatives. Provider: Zeeg GmbH, Friedrichstraße 114 a, 10117 Berlin, Germany. Use governed by Zeeg's Terms and Conditions, Privacy Notice, and GDPR Declaration.
• Odoosupporting vendorTechnology or IntegrationUsed together with HubSpot for newsletter distribution and recipient-list management; also powers regenold's public jobs board (odoo.regenold-group.com/jobs). Engaged as a data processor under Art. 28 GDPR for newsletter purposes.
• Matomo (open-source web analytics)supporting vendorTechnology or IntegrationOpen-source web analytics software used on the regenold website for statistical analysis of visitor traffic. Operated either on regenold's own servers or with a provider within the European Union, with truncated/anonymised IPs and no cross-source data merging. Used only after explicit opt-in consent under Art. 6(1)(a) GDPR.
• nutracompliance.comadjacent brandGTM or Marketing PartnerLinked destination site for regenold's 'Food & Cosmetics' solution area ('Food & Cosmetics → nutracompliance.com'), indicating an affiliated or co-branded platform addressing food supplement and cosmetics regulatory compliance adjacent to regenold's core services.
• JensonR+ (Ireland) Ltdcore legal entityStrategic or Co-development PartnerJensonR+ (Ireland) Ltd is the legal entity through which 'regenold Ireland' trades; it holds the Manufacturing and Importation Authorisations (MIA and IMP MIA) for both commercial and investigational medicinal products that underpin regenold Ireland's EU batch release offering. Registered address: 104 Lower Baggot Street, Dublin 2.
• Health authorities — MHRA, HPRA, INFARMED, EMA and national EU authoritiesoperational dependencyOthersRegenold works directly with health authorities — MHRA (UK), HPRA (Ireland), INFARMED (Portugal), EMA and national competent authorities across the EU — for scientific advice, marketing authorisations, clinical trial applications (CTIS), batch certification, pharmacovigilance, and inspections. Long-standing relationships and 'hands-on' daily engagement are highlighted as differentiators.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• SFL Regulatory Affairs & Scientific Communication: Specialised regulatory affairs and scientific communications consultancy serving pharma and medical device clients — closely comparable niche regulatory focus but smaller scale than regenold.
• Advarra (formerly IntegReview IRB / Theorem Clinical): Clinical research services provider including regulatory and ethics review, with growing EU footprint — emerging player addressing adjacent regulatory and clinical compliance needs.

Direct peers

• PharmaLex (now part of Cencora): One of the largest specialised regulatory affairs and consulting service providers globally, offering pharma, biotech and medical device regulatory, PV, quality and market access services — a near-direct comparable to regenold's core offering, with a broader geographic footprint.
• Maetrics: Regulatory and quality compliance consultancy for medical devices and pharmaceuticals, with strong MDR/IVDR focus and QMS, audit and validation services — comparable to regenold's Quality & Compliance and device regulatory lines.
• Voisin Consulting Life Sciences: Independent European life sciences consultancy focused on regulatory strategy, clinical development, medical devices and combination products — closely comparable to regenold's integrated regulatory and device offering and similar mid-sized scale.
• BlueReg: European pharma regulatory affairs and drug development consultancy offering MAAs, scientific advice and lifecycle services — directly comparable to regenold's pharmaceutical regulatory and lifecycle service line.
• RQM+: Regulatory and quality consultancy with deep MDR/IVDR focus, including Notified Body readiness, clinical evaluation, and post-market activities — directly comparable to regenold's Medical Devices, IVD and SaMD service lines.

Broad incumbents

• Charles River Laboratories: Global CRO/CDMO offering preclinical, clinical, manufacturing and regulatory consulting — overlaps with regenold's preclinical, CMC and regulatory services as part of a much wider portfolio.
• ICON plc: Global CRO providing clinical, regulatory, laboratory and consulting services across all major geographies — a broad incumbent that competes for enterprise regulatory mandates alongside regenold.
• Parexel International: Large global CRO (now privately held under EQT/Goldman Sachs) offering full clinical, regulatory and market access services; overlaps with regenold's regulatory and market access offerings as part of a much broader CRO portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/regenold-gmbh

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries5 records

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 Dr. Regenold GmbH