We provide comprehensive services related to regulatory activities both for medicinal products and medical devices.

Medicinal products

• -  Preparation of documentation for marketing authorization (MA) application
     – national, DCP and MRP procedures
• -  Compilation of complete MA dossier acc. to regulatory regulations
     and legislature
• -  Processing of MA dossier into eCTD/NeeS format
• -  Submission of an application for a new marketing authorization / variation
     / extension and ensuring a smooth run of the whole procedure
• -  Creation of Non-clinical and Clinical Overviews
• -  Preparation of MA application in eAF format
• -  Creation and editing of SmPC and PIL
• -  PIL readability / user testing
• -  Creation of complete documentation for OTC Switch
• -  Preparation of communication with regulatory authorities in the Czech Republic
     and Slovakia

Medical devices

• -  Administration of the Registry of Medical Devices (RZPRO)
• -  Notification of manufacturer / distributor activities
• -  Notification of medical devices