Regulatory affairs of human drugs, veterinary drugs
National Registration
Central, DCP, MRP Registration
Variations both Type
Renewal of Registration
Transfer of Marketing Authorisation
Translation of essential documents in 11 languages
Converting of existing dossier to a real eCTD.
Regulatory Affairs Services and Licensing
medical devices
food supplements
diagnostic substances
cosmetics registration
Clinical Trial I-IV
Preparing the Study Protocol and CRF
Project Management
Translation of essential documents
Selection of centres
Selection of special patients groups
Feasibility analyses
Trial approval procedure by Health authorities and EC
Monitoring incl. source data verification
Audits, quality assurance
Marketing
Drug Marketing Analyses for human, veterinary drugs and medical devices
Marketing Research and Consulting
Categorisation and Price Assessment of the products
Assessment of Import Price by Ministry of Finance
Assessment of Sale Price by General or National Health Insurance
Representation of Drugs (very large database of customers/doctors)
Pharmakovigilance of the Drugs