The registration of a drug is the basic requirement for its launch to the pharmaceutical market. To register a drug quickly and successfully, a thorough knowledge of the processes and required documentation is essential.


We provide professional consulting and services linked to the registration of a medicinal product:

  • preparation of application and completion of documentation for submission
  • administrative services, including preparation of e-forms (evar)
  • representation before the national authority (State Institute for Drug Control , SIDC)
  • professional translation of texts (SPC, PIL, packaging)
  • checking package graphics (mock-ups)
  • consulting on post-authorization obligations of the MA holder
  • monitoring legislation and notification of changes thereof


We offer the service “Qualified person for pharmacovigilance in the Slovak Republic”, which involves:

  • dealing with communication between local authority (State Institute for Drug Control, SIDC) and the Qualified person for pharmacovigilance (QPPV)
  • co-operation with the MA holder and SIDC when reporting undesirable effects
  • translation of DHPC and educational materials and co-operation in their approval
  • pharmacovigilance training for employees
  • monitoring legislation and notification of changes thereof
  • monitoring local literature, compilation of reports and professional translations

Interested in our services?

We are happy to answer any questions you may have.

Where to find us

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