What Medfiles does

Medfiles Ltd is a privately held Finnish full-service Contract Research Organization founded in 1987 and headquartered in Vantaa, Finland. The company delivers regulatory affairs, pharmacovigilance, and clinical trial support across five regulated verticals: human medicines, veterinary medicines, medical devices and IVDs, drug-device combinations, and food and feed products. Its service portfolio spans the full product lifecycle — from CMC documentation, marketing authorization applications, and QMS/technical documentation setup, through pharmacovigilance system establishment (including QPPV services), ICSR handling, and post-market surveillance, to lifecycle maintenance and labelling.

The business runs on a professional services model: engagements are quote-based and tailored to client scope, with revenue generated through time-and-materials consulting delivered by 95+ in-house regulatory experts. Medfiles reaches customers through direct sales (phone, contact forms, industry events), supported by content marketing, newsletters, and topic-specific webinars. The client base spans 160+ organizations in 2025, including enterprise pharma (e.g., Janssen, Desitin, Herantis Pharma), veterinary (Hankkija), med-device (CutoSense), and life sciences (Harmonia Life) customers. The firm operates primarily in Europe, with cross-border capabilities into the US and international markets, and maintains a corporate affiliation with Japan's WDB Group — reflected in its trilingual English/Finnish/Japanese web presence. No funding rounds, M&A activity, or AI/ML capabilities are disclosed in the available source material; the company presents as a mature, organically scaled regulatory consultancy.

Name

Medfiles

Legal name

Medfiles Ltd

Website

https://medfiles.eu

Company type

Private

Founded year

1987

Operating status

Operating

Headcount range

101–250 employees

Short description

Medfiles is a Finnish full-service CRO founded in 1987, providing regulatory affairs, pharmacovigilance, and clinical trial support across human and veterinary medicines, medical devices, food, and feed products to 160+ clients in Europe and internationally.

Ownership category

akta.pro rank

Headquarters

HQ city

Kuopio

HQ country

Finland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Affairs Consulting: Professional consulting services providing regulatory strategy, CMC, marketing authorization applications, and maintenance services for human medicines, veterinary medicines, medical devices, food, and feed products.
2. Pharmacovigilance Services: Post-authorisation safety monitoring services including PV system setup, adverse event processing, ICSR handling, and QPPV services for pharmaceutical and veterinary products.
3. Clinical Trials Services: Clinical trial safety services and support for medicinal products and food products undergoing regulatory evaluation.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Medfiles provides outsourced regulatory affairs, pharmacovigilance, clinical trials, and post-market safety consulting services to pharmaceutical, veterinary, medical device, IVD, drug-device combination, food, and feed companies. Its offerings span the full product lifecycle, including CMC documentation, marketing authorization applications and maintenance, PV system setup, QPPV services, ICSR management, QMS development, clinical and performance evaluations, and post-market surveillance.

Product overview

Medfiles is a regulatory consulting services company offering a comprehensive portfolio of expert services across human medicines, veterinary medicines, medical devices and IVDs, drug-device combinations, food, and feed products. The core offering comprises Regulatory Affairs Services (covering CMC, marketing authorisations, and local regulatory affairs), Pharmacovigilance Services (including PV system setup, adverse event processing, ICSR management, and QPPV services), Clinical Trials Services, Medical Device & IVD Services, Drug-Device Combination Products Services, Food Regulatory Services (including novel foods, health claims, and labelling), and Feed Regulatory Services. Founded in 1987, the company operates with 95+ highly qualified experts serving 160+ clients, providing practical and flexible solutions for businesses of all sizes in securing regulatory approvals and maintaining post-market safety compliance.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Affairs Services Comprehensive regulatory affairs consulting covering CMC documentation, new marketing authorisation applications, marketing authorisation maintenance, and local regulatory affairs across EU and international markets. Targeted at pharmaceutical, veterinary, medical device, food, and feed companies seeking regulatory strategy and lifecycle support.
• Pharmacovigilance Services Post-authorisation safety monitoring including PV system setup, adverse event processing, ICSR management, QPPV services, and medical information support for human and veterinary medicines. Designed for marketing authorisation holders needing compliant safety surveillance.
• Clinical Trials Services Clinical trial safety services and regulatory support for medicinal products, ensuring compliance with GCP requirements throughout the trial lifecycle. Targeted at pharmaceutical and biotech sponsors running clinical trials.
• Medical Device & IVD Services Quality management system (QMS) development, technical documentation, clinical and performance evaluations, regulatory registrations, post-market surveillance, and labelling services for medical devices and in vitro diagnostics. Targeted at medical device and IVD manufacturers needing EU MDR compliance.
• Drug-Device Combination Products Services End-to-end regulatory strategy, development documentation, clinical trials, CMC support, approvals and conformity assessment, safety surveillance, and lifecycle management for drug-device combination products in the EU. Targeted at manufacturers of combination products.
• Food Regulatory Services Novel food applications, GRAS/NDI/FAP registrations, health claim applications, food and supplement labelling, FSGs and FSMPs registration, regulatory positioning and strategies, and clinical studies for food products. Targeted at food, food supplement, and nutrition companies needing EU regulatory approval.
• Feed Regulatory Services Feed material and additive registrations, GRAS and FAP certifications, labelling and marketing materials, and regulatory positioning for feed products including feed for particular nutritional purposes. Targeted at feed manufacturers and distributors.

Quantifiable outcome

• 35+ years of regulatory affairs experience serving clients in the pharmaceutical and related industries
• +1 more outcomes

Named customers6 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• WHO Global Traditional Medicine CentrecoreStrategic or Co-development Partner · 17 December 2025Medfiles Ltd participated as an expert contributor at the 2nd WHO Global Traditional Medicine Summit in New Delhi, organized by the WHO Global Traditional Medicine Centre in collaboration with India's Ministry of Ayush. Medfiles experts contributed to discussions on Ashwagandha quality benchmarks, therapeutic applications, and evidence-based standards for responsible global use of traditional medicine.
• WDB GroupcoreOthersWDB Group is listed as the parent company or corporate affiliation of Medfiles. WDB Group (www.wdbhd.co.jp) is a Japanese healthcare and life sciences consulting organization with international operations.

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• PharmaLex (now part of Cencora/Allergan Aesthetics): PharmaLex is a specialized regulatory affairs, pharmacovigilance, and consulting firm serving pharma, biotech, and medtech—directly comparable to Medfiles' core service portfolio across the same regulated verticals. Acquired by Cencora, it represents the scaled version of Medfiles' model.
• ProPharma Group: ProPharma Group is a regulatory, compliance, and pharmacovigilance consulting firm serving pharma, medical device, and biotech clients globally. It competes head-to-head with Medfiles in regulatory affairs outsourcing and PV system setup.
• Arriello: Arriello is a European regulatory affairs and pharmacovigilance services firm, closely comparable to Medfiles in size, service mix (regulatory + PV + compliance), and target client segments across pharma and medtech.
• CIRS Group (Chemical Inspection & Regulation Service): CIRS Group is a regulatory consulting firm with a similar service mix spanning pharma, medical devices, food, and chemicals, with strong European and Chinese market coverage. It is a close functional peer to Medfiles.
• Regulis: Regulis is a European regulatory affairs and pharmacovigilance consulting firm serving pharma, biotech, and medical device clients. It is a small, niche peer directly comparable to Medfiles' specialized offering.

Broad incumbents

• IQVIA: IQVIA is the largest global CRO offering integrated clinical, regulatory, and commercial services across 100+ countries. It competes with Medfiles on regulatory affairs contracts and sets the pricing benchmark in the market.
• ICON plc: ICON is a top-3 global CRO with extensive regulatory affairs capabilities after its PRA Health Sciences merger. It is a broad incumbent alternative for clients evaluating Medfiles for regulatory outsourcing.
• Charles River Laboratories: Charles River provides integrated drug discovery, development, and regulatory services, with strong safety/pharmacovigilance capabilities. As a broad incumbent, it competes for larger bundled regulatory engagements.
• Parexel International: Parexel is a major global CRO with deep regulatory consulting and pharmacovigilance practices. It serves the same enterprise pharma clients (e.g., Janssen-adjacent) as Medfiles, typically on larger global programs.
• Labcorp Drug Development (Fortrea): Fortrea (spun off from Labcorp) is a top-tier global CRO with regulatory and clinical services. It is a broad incumbent that competes for enterprise pharma regulatory outsourcing RFPs.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/MedfilesCRO
• LinkedInlinkedin.com/company/oy-medfiles-ltd

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 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 Medfiles