Whether you need project-related assistance or are seeking to outsource entire pharmacovigilance processes – our knowledgeable consultants will be there for you.
Pharmacovigilance quality system documentation is created for each client individually.
Contact us with confidence. Inquire about pharmacovigilance services at
If you are looking for local pharmacovigilance services in HR/B&H/CS/MN/MK, we are ready to:
  • Act as local contact person /deputy of local contact person for authorities
  • Perform local literature search (from any source of information about your medicines)
  • Perform local personnel pharmacovigilance trainings 
  • Process suspected adverse reactions (collection, translation and forwarding of the information, follow-up reports)
  • Reports submission to regulatory authorities
If you are looking for general post-marketing pharmacovigilance support, we are ready to:
  • Appoint EU QPPV 
  • Establish medical affairs support
  • Register your company in Eudravigilance 
  • Manage pharmacovigilance data
  • Process of case data 
  • Prepare adverse reaction reports
  • Perform adverse events / reactions reporting to competent authorities 
  • Enter product and safety data to Eudravigilance 
  • Perform literature monitoring (worldwide and local)
  • Prepare periodic safety update reports (PSURs)
  • Prepare and update Risk Management Plans (RMPs)
  • Evaluate safety data
  • Prepare and regularly update product(s) reference safety information / Company core data sheet
  • Perform regulatory submissions monitoring
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