Oy Medfiles Ltd
Consultancy providing regulatory, clinical, pharmacovigilance, and product-compliance services for human and veterinary medicines, medical devices/IVDs, food, feed and cosmetics. Services include regulatory strategy and dossier preparation, post-authorisation pharmacovigilance and QPPV provision, clinical trial support (CTIS/eTMF submissions and monitoring), product labelling and health-claim compliance, regulatory gap analyses and safety/risk assessments for novel ingredients across EU and selected non-EU markets.
Industries
N/A
Nr. of Employees
small (1-50)
Services
Regulatory strategy, dossier preparation and submission (centralised, decentralised, mutual recognition and national procedures), variations and lifecycle maintenance.
PV system setup and maintenance, QPPV services, PSMF maintenance, ICSR processing, literature screening, periodic safety reporting, signal management and vendor oversight.
Protocol development, monitoring, safety management, project management, eTMF deployment, and CTIS submission support for interventional and investigator-initiated studies.
MDR/IVDR compliance, clinical evaluation reports, planning and conduct of clinical investigations, PMCF and GCP/ISO 14155-aligned guidance; QMS and technical documentation support and notified body interaction readiness.
Novel food and ingredient assessments, food supplement compliance, labelling and health-claim applications, feed ingredient regulatory advice and cosmetic ingredient safety assessments.
Advice on establishing an EU MAH, GMP/GDP compliance, importation requirements, QP/batch release considerations and national pricing/reimbursement and HTA implications.
Regulatory strategy, dossier preparation and submission (centralised, decentralised, mutual recognition and national procedures), variations and lifecycle maintenance.
PV system setup and maintenance, QPPV services, PSMF maintenance, ICSR processing, literature screening, periodic safety reporting, signal management and vendor oversight.
Protocol development, monitoring, safety management, project management, eTMF deployment, and CTIS submission support for interventional and investigator-initiated studies.
MDR/IVDR compliance, clinical evaluation reports, planning and conduct of clinical investigations, PMCF and GCP/ISO 14155-aligned guidance; QMS and technical documentation support and notified body interaction readiness.
Novel food and ingredient assessments, food supplement compliance, labelling and health-claim applications, feed ingredient regulatory advice and cosmetic ingredient safety assessments.
Advice on establishing an EU MAH, GMP/GDP compliance, importation requirements, QP/batch release considerations and national pricing/reimbursement and HTA implications.
Expertise Areas
- Clinical trial management and monitoring
- Regulatory affairs for human medicines (EU procedures)
- Pharmacovigilance and post-authorisation safety systems
- Medical device and IVD regulatory compliance and clinical evaluation
Key Technologies
- CTIS submissions and sponsor workspace workflows
- Electronic Trial Master File (eTMF) systems
- Regulatory safety database monitoring and ICSR processing (EudraVigilance workflows)
- Risk Management Plan (RMP) development
News & Updates
Live webinar covering recent changes in food legislation and practical implications for companies (webinar held 17.3.2026).
Guidance on compiling robust Module 3 (quality/CMC) sections for EU marketing authorisation applications.
Answers on procedures, timelines and classification for EU marketing-authorisation variations.
Overview of national requirements and compliance considerations for pharmaceutical marketing in Finland.
Comparative analysis of regional post-marketing safety frameworks and implications for marketing-authorisation holders.
Overview of technological and regulatory trends affecting animal health product development and lifecycle.
Live webinar covering recent changes in food legislation and practical implications for companies (webinar held 17.3.2026).
Guidance on compiling robust Module 3 (quality/CMC) sections for EU marketing authorisation applications.
Answers on procedures, timelines and classification for EU marketing-authorisation variations.
Overview of national requirements and compliance considerations for pharmaceutical marketing in Finland.
Comparative analysis of regional post-marketing safety frameworks and implications for marketing-authorisation holders.
Overview of technological and regulatory trends affecting animal health product development and lifecycle.