Medius AG
Medius AG is a Basel-area consulting firm providing drug regulatory affairs, quality management, and pharmacovigilance services to pharmaceutical companies seeking access to the Swiss and Liechtenstein markets, acting as a Swissmedic establishment license holder and Marketing Authorisation Holder for 50+ licensed products.
- Company typePrivate
- Founded1997
- HeadquartersMuttenz, Switzerland
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Medius AG does
Medius AG is a privately-held Swiss consulting firm headquartered in Muttenz, near Basel, specializing in drug regulatory affairs, quality management, and pharmacovigilance services for the pharmaceutical industry. Founded in 1997, the company holds a Swiss establishment license — a regulatory prerequisite for any entity submitting marketing authorization applications to Swissmedic — and offers an integrated suite of services covering the full product lifecycle: regulatory submissions and lifecycle management, GDP-quality management systems, batch release, pharmacovigilance reporting, and the provision of legally mandated Responsible Persons under Swiss law (art. 17 MPLO, art. 65 TPO, art. 25 TPAO). Beyond project-based consulting, Medius acts as Marketing Authorisation Holder (MAH) for more than 50 licensed pharmaceutical products spanning cardiovascular, oncology, and immunology therapeutic areas (including brands such as Sintrom, Arimidex, Casodex, Qarziba, Latuda, Ogivri, and Hulio), and provides interim licence-holder services for clients acquiring or transferring authorizations.
The business operates a B2B professional services model with customized, quote-based engagements sold through direct enterprise field sales to international pharmaceutical companies — particularly those without Swiss subsidiaries seeking market access — and to pharma companies already operating in Switzerland that require ongoing regulatory and quality support. The company serves more than 30 regular clients, with the majority in long-term relationships, and has expanded service coverage into Liechtenstein alongside Switzerland. In June 2024, regenold GmbH acquired a controlling stake, and the leadership team was expanded with the appointments of Dr. Manuel Vögtli and Arina Mathys to support service-line growth.
The firm is small but credentialed, with approximately 10 professionals holding PhDs and Masters in chemistry, toxicology, pharmacy, and related disciplines and combining for over 100 years of industry experience. Its strategic positioning is anchored in geographic and regulatory specialization within the Basel BioValley life-sciences cluster, monetizing the structural requirement that foreign pharma firms use a local license holder to enter the Swiss and Liechtenstein markets. Revenue and pricing details are not publicly disclosed.
Medius AG firmographics
Firmographics- Name
- Medius AG
- Legal name
- Medius AG
- Website
- https://medius.ch
- Company type
- Private
- Founded year
- 1997
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Medius AG is a Basel-area consulting firm providing drug regulatory affairs, quality management, and pharmacovigilance services to pharmaceutical companies seeking access to the Swiss and Liechtenstein markets, acting as a Swissmedic establishment license holder and Marketing Authorisation Holder for 50+ licensed products.
- Ownership category
- akta.pro rank
Where Medius AG is headquartered
LocationHeadquarters
- HQ city
- Muttenz
- HQ country
- Switzerland
- HQ region
- Europe
Offices1 record
Markets served
Medius AG business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Others
Revenue model
- Regulatory Affairs Consulting Services: Professional consulting services for drug regulatory affairs including marketing authorization applications, lifecycle management, and Swissmedic liaison. Services provided to pharmaceutical companies for market access to Swiss market.
- Quality Management Services: GDP-Quality Management System creation and maintenance, authority inspections management, audits, batch release, and pharmacovigilance services.
- Marketing Authorization Holder (MAH) Services: Acting as license holder for medicinal products on behalf of clients, providing responsible person functions, and enabling market access for international companies without Swiss subsidiaries.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
Medius AG product offering
Product offeringCore offering
Medius AG is a Basel-based consulting and service company that provides drug regulatory affairs, quality management (GDP), and pharmacovigilance services to national and international pharmaceutical and healthcare product companies. It prepares and submits marketing authorisation applications to Swissmedic, acts as Marketing Authorisation Holder (MAH) for a portfolio of over 50 licensed products, provides Responsible Person functions under Swiss law, and enables fast and reliable access to the Swiss pharmaceutical market by holding a local establishment licence.
Product overview
Medius AG is a consulting and service company providing drug regulatory affairs and quality management services to the pharmaceutical industry. The company operates as a unified service offering rather than a modular software platform. The core services comprise Regulatory Affairs Management (covering marketing authorization applications, lifecycle management, and technical writing), Quality Management (encompassing GDP-quality systems, inspections, and batch release), and Responsible Person Functions (GDP, pharmacovigilance, and promotion). Additionally, Medius offers Marketing Authorisation Holder services for companies seeking market entry to Switzerland, acting as local licence holder for their products. The company holds an establishment licence enabling direct submissions to Swissmedic and serves as MAH for a portfolio of over 50 licensed pharmaceutical products.
Differentiator
Problem solved
Functional benefit
Quantifiable outcome
- Over 100 years of combined professional experience on team
- +1 more outcomes
Companies that use Medius AG
Customer profileNamed customers1 record
Segments2 records
Ideal customer profiles2 records
Medius AG technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Medius AG partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Huesler-ConsultingminorCollaboration announced in December 2022. Welcome of Fransziska to the Medius team as part of the partnership. Strategic consulting partnership in regulatory affairs services.
Scale indicators3 records
Recent moves7 records
Expansion highlights5 records
Medius AG competitors and assessment
Company assessmentDirect peers
- MMS Holdings: Clinical research and regulatory services firm providing regulatory affairs, quality, and pharmacovigilance support to pharma and biotech — significant overlap with Medius' offerings.
- BlueReg: European consulting firm specialised in regulatory affairs, pharmacovigilance, and clinical development for pharma and biotech — directly comparable service mix to Medius.
- PharmaLex (Cencora PharmaLex): Global regulatory affairs and pharmacovigilance consulting firm providing marketing authorisation holder services, regulatory strategy, and quality management — closest direct competitor to Medius in the regulatory outsourcing niche.
- Arriello: European regulatory and pharmacovigilance consultancy supporting pharma market entry and lifecycle management — competes directly on the MAH and regulatory consulting niche.
- Voisin Consulting Life Sciences (VCLS): European regulatory affairs and pharmacovigilance consultancy supporting pharma companies through product development, market entry, and post-approval lifecycle — direct competition in regulatory strategy.
- Freyr Solutions: Regulatory affairs, pharmacovigilance, and quality consulting firm offering end-to-end outsourced regulatory services to pharma — directly comparable business model and target customer base.
Emerging players
- Clinipace Worldwide: Mid-sized CRO and regulatory consulting firm providing clinical and regulatory services to pharma/biotech — partial overlap with Medius' regulatory offerings and a regional-style competitor.
Broad incumbents
- IQVIA: Global CRO offering regulatory affairs, pharmacovigilance, and quality management as part of a broad life sciences services portfolio — competes via scale, multi-jurisdiction coverage, and pharma relationships.
- ICON plc: Global CRO with extensive regulatory consulting, pharmacovigilance, and quality services — competes on enterprise-scale regulatory outsourcing deals.
- Parexel International: Large global CRO providing comprehensive regulatory, clinical, and pharmacovigilance services — competes with Medius on multi-country regulatory engagements and bundled service deals.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
Medius AG social profiles
Digital presenceMedius AG financial estimates
Financial estimateRevenue estimate
Valuation estimate
Medius AG leadership team
Management profileNumber of profiles
Profiles10 records
Medius AG funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Medius AG 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 Medius AG
What does Medius AG do?
Medius AG is a Basel-based consulting and service company that provides drug regulatory affairs, quality management (GDP), and pharmacovigilance services to national and international pharmaceutical and healthcare product companies. It prepares and submits marketing authorisation applications to Swissmedic, acts as Marketing Authorisation Holder (MAH) for a portfolio of over 50 licensed products, provides Responsible Person functions under Swiss law, and enables fast and reliable access to the Swiss pharmaceutical market by holding a local establishment licence.
Is Medius AG a public or private company?
Medius AG is a private company. It is classified as private equity controlled and is currently operating.
When was Medius AG founded?
Medius AG was founded in 1997. It employs 1 to 10 people.
Where is Medius AG based?
Medius AG is headquartered in Muttenz, Switzerland, in the Europe region.
How does Medius AG make money?
Three revenue lines are on record. Regulatory Affairs Consulting Services are the primary driver. The others are quality Management Services and marketing Authorization Holder (MAH) Services.
Who are Medius AG's main competitors?
Direct peers on record are MMS Holdings, BlueReg, PharmaLex (Cencora PharmaLex), Arriello, Voisin Consulting Life Sciences (VCLS) and Freyr Solutions. Clinipace Worldwide is listed as an emerging player. Broad incumbents are IQVIA, ICON plc and Parexel International.
Does Medius AG have an API?
No public API is recorded for Medius AG.