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Node Niconex Medical

Niconex Medical


Country headquarter:
Market presence:
Cyprus and Greece included for specific services.
General description:

At Niconex Medical, we provide a single point of contact to interact with clients or clients’ internal cross-functional team members from relevant departments, third-party business contacts and National Competent Authorities to coordinate procedures according to strict timelines and achieve value-driven, accurate services to meet client requirements.

Areas of regulatory/reimbursement support:

Marketing Authorisation:
•Submission of dossiers for MA applications (MAA)
•Co-ordination of MA Applications to ensure timely approvals
•Local regulatory intelligence

Product Maintenance
•Post-approval notifications
•Sunset Clause
•Local contact point

Document Preparation:
•Regulatory review of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling.
•Preparation / Translations of Product Information (SmPC, Labeling and PIL) to local language.
•Non-clinical and clinical literature overviews.
•Regulatory review of packaging material.
•Regulatory review of promotional material.

Market access:
•Pricing applications.
•Sales Submissions.

Company website


The eHealth Hub project has received funding from the European Union’s Horizon 2020
Research and Innovation Programme under Grant Agreement No727683.