We offer you the safety of our experience

 

Our services


Our experience

In the past we have prepared several successfully realized documentations for well‑established use procedures and are now offering complete regulatory services.

 

Regulatory services


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