EUDRAC
EUDRAC is a European regulatory affairs and pharmacovigilance consultancy founded in 2002, serving pharmaceutical, medical device, and nutritional supplement companies with end-to-end support across R&D, marketing authorisation, and post-approval activities.
- Company typePrivate
- Founded2002
- HeadquartersChalgrove, United Kingdom
- Headcount11–50
- GTM typeB2B
- OfferingServices
What EUDRAC does
EUDRAC GmbH (European Drug Regulatory Affairs Consulting) is a privately held regulatory affairs and pharmacovigilance consultancy founded in 2002 by Ute Junghanns and headquartered in Heidelberg, Germany, with additional offices in Nice, France and Zug, Switzerland. The firm provides B2B professional services to pharmaceutical, medical device, and nutritional supplement companies, covering the full product lifecycle from R&D and clinical trials through marketing authorisation applications, market launch, and post-authorisation maintenance. Service offerings include scientific dossier writing, publishing, product information and labelling, linguistic review, pharmacovigilance support, CE Mark certification, technical file preparation, QMS and medical device vigilance, supply chain consulting (including FMD compliance), wholesale dealer licence support, and competitor review.
The business operates on a sales-led, quote-based professional services model with customised packages tailored to both small and large healthcare companies. The firm is founder-owned and founder-managed, with Ute Junghanns as Managing Partner, Dr. Hendrik Junghanns as Managing Director, and Eva Sambel as Senior Director leading the German office. The staff consists of pharmacists, chemists, biologists, a medical doctor, and pharmacovigilance/regulatory affairs specialists, with the management team holding more than 25 years of industry experience and the majority of staff holding more than 10 years of experience. Underlying technology is human expertise-driven; no proprietary platform, API, or AI tooling is disclosed.
EUDRAC generates revenue through professional services fees tied to regulatory project scopes (e.g., marketing authorisation submissions, variations, renewals, CE Mark work, dossier publishing, linguistic review). Its go-to-market relies on direct client engagement, a multi-language corporate website (EN/DE/FR), and repeat/referral business built on 20+ years of regulatory delivery. The firm reports a high level of repeat business and ongoing long-term assignments, and has recently extended service lines into supply chain compliance, wholesale dealer licensing, competitor review, and international regulatory frameworks covering North America (FDA, Health Canada) and Asia-Pacific markets.
EUDRAC firmographics
Firmographics- Name
- EUDRAC
- Legal name
- EUDRAC GmbH
- Website
- https://eudrac.com
- Company type
- Private
- Founded year
- 2002
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- EUDRAC is a European regulatory affairs and pharmacovigilance consultancy founded in 2002, serving pharmaceutical, medical device, and nutritional supplement companies with end-to-end support across R&D, marketing authorisation, and post-approval activities.
- Ownership category
- akta.pro rank
Where EUDRAC is headquartered
LocationHeadquarters
- HQ city
- Chalgrove
- HQ country
- United Kingdom
- HQ region
- Europe
Offices3 records
Markets served
EUDRAC business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Regulatory Affairs Consulting: Professional consulting services for medicinal products, medical devices, and nutritional supplements covering research & development, marketing authorisation applications, and post-authorisation activities across EU countries.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels2 records
EUDRAC product offering
Product offeringCore offering
EUDRAC is a European regulatory affairs and pharmacovigilance consultancy that helps pharmaceutical, medical device, and nutritional supplement companies drive products through development, registration, market launch, and post-approval activities across all EU countries. Services include medicinal products R&D (EAP, clinical trials, IB/IMPD writing, ODD, PIP), marketing authorisation applications (scientific dossier writing, publishing, product information, linguistic review), post-authorisation maintenance (variations, renewals, OTC switch), CE marking and technical files for medical devices, nutritional supplement regulatory strategy, and specialised offerings such as wholesale dealer licence support, supply chain consulting, competitor review, and training.
Product overview
EUDRAC is a European regulatory affairs and pharmacovigilance consultancy company offering comprehensive consulting services to drive products through development, registration, market launch, and post-approval activities across all EU countries. The company's service portfolio includes four main pillars: (1) Medicinal Products Services covering Research & Development (Early Access Program, Clinical Trials, Orphan Drug Designation, PIP), Marketing Authorisation Applications (Scientific Dossier Writing, Publishing, Linguistic Review), and Post Authorisation support (MAH maintenance, Variations, Renewals, OTC switch); (2) Medical Devices Services including CE Mark, Technical Files, and QMS & Vigilance; (3) Nutritional Supplements Regulatory Services for EU and international markets; and (4) Specialised Services including Supply Chain, Wholesale Dealer Licence support, Competitor Review, Training, and SME registration support. The company is based in Germany, France, and Switzerland since 2002.
Differentiator
Problem solved
Functional benefit
Products and services
- Medicinal Products Research & Development Services
Quantifiable outcome
- High level of repeat business and ongoing long-term assignments with clients
Companies that use EUDRAC
Customer profileSegments3 records
Ideal customer profiles3 records
EUDRAC technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
EUDRAC partnerships and signals
Strategic signalScale indicators3 records
Recent moves6 records
Expansion highlights4 records
EUDRAC competitors and assessment
Company assessmentMarket position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key highlights6 records
Customer concentration
EUDRAC social profiles
Digital presenceEUDRAC financial estimates
Financial estimateRevenue estimate
Valuation estimate
EUDRAC leadership team
Management profileNumber of profiles
Profiles3 records
EUDRAC funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
EUDRAC M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about EUDRAC
What does EUDRAC do?
EUDRAC is a European regulatory affairs and pharmacovigilance consultancy that helps pharmaceutical, medical device, and nutritional supplement companies drive products through development, registration, market launch, and post-approval activities across all EU countries. Services include medicinal products R&D (EAP, clinical trials, IB/IMPD writing, ODD, PIP), marketing authorisation applications (scientific dossier writing, publishing, product information, linguistic review), post-authorisation maintenance (variations, renewals, OTC switch), CE marking and technical files for medical devices, nutritional supplement regulatory strategy, and specialised offerings such as wholesale dealer licence support, supply chain consulting, competitor review, and training.
Is EUDRAC a public or private company?
EUDRAC is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was EUDRAC founded?
EUDRAC was founded in 2002. It employs 11 to 50 people.
Where is EUDRAC based?
EUDRAC is headquartered in Chalgrove, United Kingdom, in the Europe region.
How does EUDRAC make money?
One revenue line is on record: regulatory Affairs Consulting.
Does EUDRAC have an API?
No public API is recorded for EUDRAC.