Bridging your regulatory needs to pharma solutions

  • Regulatory affairs

    For companies in the healthcare and pharmaceutical sector
  • Pharmacovigilance

    Monitoring of your products’ safety profile as well as medical literature for identifying potential adverse reactions
  • Information

    Timely information on all new requirements and updates in medicinal products legislation and pharmacovigilance amendments
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Pharmacovigilance services

  • EU QPPV services (Registration in the EudraVigilance database, ICSR/SUSAR reporting, XEVMPD - electronic submission of information on medicines)
  • Collecting, processing and evaluation of ICSRs (Individual Case Safety Report) as well as reporting of serious ADR (Adverse Drug Reaction) to EudraVigilance.
  • Local contact QPPV (Bulgaria and Romania) and related Pharmacovigilance services to support Marketing Authorisation Holders (MAH) for achieving compliance with EU regulatory requirements (Regulation 1235/2010 and Directive 2010/84/EC) and local obligations to assign a local point of contact for pharmacovigilance for every registered product.
  • Literature screening and follow-up assessment of relevant articles/scientific extracts. Medical review of cases in literature can help you identify important signals concerning the safety profile of your products.

 

If you wish to report an adverse event, please use our "Contact Us" form. Thank you. We will revert to you as soon as possible.