european pil user testing in most languages

Czech and Slovak Republic
Regulatory and Pharmacovigilance Services

  • Strategic Regulatory Consultations for the Czech Republic
  • Submissions and representation to SUKL
  • National submissions
  • RMS and CMS for DCP and MRP in the Czech Republic
  • Pricing and reimbursement
  • Maintenance of existing licenses
    • Verification of acceptability of regulatory documents for the national authorities before submission and suggesting improvements where deemed necessary;
    • Providing advice and information to concerning local regulations.
    • Translation of regulatory documents (i.e. summary of product characteristics, patient information leaflets, labeling of packaging materials) into the applicable national language.
    • Proofreading of printed packaging materials, which need to be or have been translated into the applicable national language before submission.
    • Suggestions for opportunities to expedite the approval process of submitted regulatory documents.

Pharmacovigilance Service for the Czech and Slovak Republic

  • establish and maintenance of a pharmacovigilance system
  • preparation of a SOP for pharamcovigilance
  • establish QPPV
  • collect, process, classify and notify all suspected adverse reactions
  • report all suspicion of serious adverse reaction to the State Authority (ICSR)
  • to conduct continuous overall pharmacovigilance evaluation during the post authorisation period
  • to keep an overview of the safety profiles and any emerging safety concerns to the medical products for which the MAH holds authorisation
  • to prepare and submit PSURs in periodical interval (EU HBD)
  • to follow up scientific literature
  • to create and maintain a database used for pharmacovigilance purposes (e.g.compilation of safety reports, electronic reporting, sharing and accessing global safety information)
  • registration with EUDRAVIGILANCE
  • arranging for a MedDRA licence at MSSO
  • electronic reporting of serious adverse reaction (ICSRs)

Preferred Readability Testing Providers for: