Cyprus and Greece included for specific services.
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:
•Submission of dossiers for MA applications (MAA)
•Co-ordination of MA Applications to ensure timely approvals
•Local regulatory intelligence
•Local contact point
•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.