EU PV System, RA

  • EU QPPV & Local QPPV in EU and WBC
  • RA Services – RA Strategy, MAA & eCTD compilations, publishing, electronic submissions, full application management services during MAA procedure, PIL Readability Testing, Variations, Consultations, Scientific Advices

  • Full range of services in area of pharmacovigilance system of medicinal products through EU QPPV and LQPPVs (where required) . Services include creation of all necessary documentation for MAH with PSMF, RMP, as well as preparation of PSURs.
  • SDEA writing and support in PV system set-up (legal framework).
  • Local pharmacovigilance procedures and LQP PV services in WBC, UK, Cyprus, Bulgaria, Romania, Croatia, Slovenia, Czech, Slovakia, Germany, Portugal, Lithuania, and rest of EU countries.
  • Range of services in area of vigilance of medical devices (MD), Field Safety Corrective Action (FSCA), Field safety Notice (FSN), Periodic Summary Reporting (PSR), Trend Reporting, including Post market surveillance (PMS), Post market clinical follow up (PMCF), Complaint and Recall.
  • Legal Representative Services – MA (medicines)/License (MDs, Food Supplements) holding services
  • Regulatory Strategy development and advise
  • EU and West Balkan countries (WBC) Legislation Consulting/Advice
  • EU and WBC consultations and Scientific Advices
  • Compiling and Submission of Marketing Authorization/Licensing/Notification Applications (for more info visit Section - EU CTD Dossier)
  • Expert consulting services - CMS (Quality), Non-Clinical, and Clinical
  • MAH/License holding services in EU and WBC
  • MAA Management during procedure (Deficiency Letters, Responses, Communication and consultations with Agencies, etc.)
  • Life-cycle management and maintenance for granted MAs in EU and WBC
  • Variations – compilations, submissions, management
  • Dossier consolidation and updating