Regulatory Services
Pharmaceuticals
Compilation and revise of dossiers for submission
Submission for new national registration procedure, renewals, and variations
Coordination of MRP/DCP procedures, follow-up of the national phase
Preparation of CTD
Translation and adaptation of SmPC, PIL and label text
Final check and approval of the Hungarian SmPC, PIL and label text revised by the Regulatory Authority
Consultancy services
Application for price reimbursement
Local contact to the Regulatory Authority
Serialization activities
Medical Devices
Registration, approvals
Translation, adaptation, and checking of label text and instruction for use
Ranking into category
Food additives, nutritional supplements, cosmetics
Notification
Translation, adaptation, and checking of label text and instruction for use
Statements related to health
Calculation of nutritive value
