Verification evidence is still being completed.
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Oy Medfiles Ltd.
Kuopio, Finland
- Verified lead
- Tuija Keinonen
- Lead status
- STATUS: VERIFIED APRIL 2026
- Leadership verification
- Chief Executive Officer
- 2026 technical specialization
- Full-Service CRO, Phase I-IV Clinical Trials, Bioanalytics, and Pharmacovigilance
- Review cycle
- 24 April 2026
- Full address
- Volttikatu 5, P.O. Box 1450, FI-70700 Kuopio, Finland
- Site coordinates
- Verification evidence is still being completed.
- Editorial review
- Memel Biotech editorial review
- Official leadership source
- Business Kuopio success-story coverage naming Tuija Keinonen as CEO of Medfiles.
- Editorial note
- Kuopio full-service CRO owned by Japan's WDB Holdings with named CEO, GCP, GLP, and GVP scope, and ISO 9001 certification.
Full-Service CRO, Phase I-IV Clinical Trials, Bioanalytics, and Pharmacovigilance
GCP, GLP, GVP scope, ISO 9001, WDB Holdings ownership
Kuopio full-service CRO owned by Japan's WDB Holdings with named CEO, GCP, GLP, and GVP scope, and ISO 9001 certification.
Review coverage
Leadership
Facility
Certifications
Capabilities
Partners
Sources
Quality
Editorial verificationMemel Biotech directory review sign-off
Report generated02 Jun 2026, 01:40
Kuopio full-service CRO owned by Japan's WDB Holdings with named CEO, GCP, GLP, and GVP scope, and ISO 9001 certification.
- Lead
- Tuija Keinonen (verified ↗)
- Address
- Volttikatu 5, P.O. Box 1450, FI-70700 Kuopio, Finland (source ↗)
- Compliance
- GCP, GLP, GVP scope · ISO 9001
- Last reviewed
- 24 Apr 2026 (1mo ago)
- Scale
- Full-service CRO operations
- Capabilities
- Phase I-IV Clinical Trial Operations · Bioanalytical Laboratory · Regulatory and Pharmacovigilance Services across EU and Japan
- Founded
- 1987
- Headcount
- 51-200
- Company page (open ↗)
Clinical profileSTATUS: VERIFIED APRIL 2026
Tuija Keinonen
Chief Executive Officer
Full addressVolttikatu 5, P.O. Box 1450, FI-70700 Kuopio, Finland
Site coordinatesVerification evidence is still being completed.
Review cycle24 April 2026
Full-service CRO operations
Kuopio, Finland. Full-Service CRO, Phase I-IV Clinical Trials, Bioanalytics, and Pharmacovigilance. Review completed on 24 Apr 2026.
Fimea, EMA, and PMDA (Japan) for regulatory oversight
GCP, GLP, GVP scope, ISO 9001, WDB Holdings ownership
Full-Service CRO, Phase I-IV Clinical Trials, Bioanalytics, and Pharmacovigilance
Kuopio full-service CRO owned by Japan's WDB Holdings with named CEO, GCP, GLP, and GVP scope, and ISO 9001 certification.
Editorial note
Medfiles is a WDB-owned full-service CRO based in Kuopio with a long-standing named CEO, documented GCP, GLP (bioanalysis), and GVP (pharmacovigilance) scope, and ISO 9001 certification.
FULL TRUST REVIEW COMPLETE
Shown only when all seven trust checks are fully mapped in the directory.
Current review cycleApril 2026
Capabilities
Core capabilities
Primary declared technical activities and areas of operating focus.
Phase I-IV Clinical Trial Operations
Bioanalytical Laboratory
Regulatory and Pharmacovigilance Services across EU and Japan
Verification source dossier
Verification source dossier
Official source set used to support leadership, physical-site, certification, and watch-note evidence.
Infrastructure
Declared infrastructure
Bioanalytical laboratory
Clinical trial operations
Regulatory and pharmacovigilance platforms
Regulatory posture
Quality system coverage
GMP / GLP / ISO-13485 / FDA-Inspected are global quality-system standards. "Verified active" means the directory confirmed the certification is current; "Review in progress" means the cert status is currently being re-verified.
- GMP
- REVIEW IN PROGRESS 2026
- GLP
- VERIFIED ACTIVE 2026
- ISO-13485
- REVIEW IN PROGRESS 2026
- FDA-Inspected
- REVIEW IN PROGRESS 2026
Verification history
Verification history
24 Apr 2026: Executive identity confirmed via official management disclosure.
24 Apr 2026: Full trust review completed.
FAQ
Frequently asked questions
- Where is Oy Medfiles Ltd. located?
- Oy Medfiles Ltd. operates from Volttikatu 5, P.O. Box 1450, FI-70700 Kuopio, Finland, Kuopio, Finland.
- Who runs Oy Medfiles Ltd.?
- Oy Medfiles Ltd. is led by Tuija Keinonen, Chief Executive Officer. Verified 24 Apr 2026.
- What certifications does Oy Medfiles Ltd. hold?
- Oy Medfiles Ltd. is documented under GCP, GLP, GVP scope, ISO 9001.
- What does Oy Medfiles Ltd. do?
- Kuopio full-service CRO owned by Japan's WDB Holdings with named CEO, GCP, GLP, and GVP scope, and ISO 9001 certification. Core capabilities: Phase I-IV Clinical Trial Operations, Bioanalytical Laboratory, Regulatory and Pharmacovigilance Services across EU and Japan.
Editorial context
Related technical briefs
Briefs that name Kuopio as a covered market or city.