We will navigate you through the regulatory labyrinth

 

Our services


Our experience

To our clients belong not only large producers but also small companies who need complete regulatory services and representation with local regulatory authorities. For these companies we create strategies for market entry and advisory services for the entire lifecycle of their products.

 

Strategy consulting


We create key-ready regulatory and market access strategies to be used in marketing medicinal products, medical devices, food supplements or cosmetics in the Czech Republic or Slovakia territory.

 

  • -  We supply the knowledge of environment and experience with regulatory rules
       based on many years of activity in the CR and SR territories
  • -  We offer a comprehensive perspective from marketing authorization
       through entering reimbursement to safety monitoring and data from real
       clinical practice
  • -  We conduct continual monitoring of changes in legislature
       and regulatory variations
  • -  We are able to offer full support including representation in negotiations
       with local authorities (SUKL, Ministry of Health, insurance companies)
  • -  We prepare a key-ready benefits and risks analysis for various strategies