“Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.”


Indicative scope of services:


  • Quality System (QS) compilation, introduction including preparation of Standard Operating Procedures (SOP)
  • Collecting – assessing reports on Adverse Drug Reactions (ADR) – Risk assessments
  • Collecting other safety data (studies, follow scientific literature, etc.)
  • Detecting safety signals, identified risks, and adopting – implementing safety measures
  • Preparation of safety data in Periodic Safety Update Reports (PSUR)
  • Risk management plans – risk minimisation measures
  • Reporting to EudraVigilance
  • Availability for PV audit of MAH, inspections and medicinal agencies


Indicative scope of services:


  • Quality System (QS) preparation with its implementation including preparation of Standard Operating Procedures (SOP)
  • Responsible Person for vigilance
    Device Specific Reports (FSCA Reports, Use Errors, Periodic Summary Reporting, Trend Reporting)
  • Introduction of any safety measures
  • Collection and evaluation of complication reports
  • Monitoring of investigation the complication
  • Medical technical support
  • Coordination – reporting incidemts to the responsible authorities
  • Reporting to the medical device vigilance system (EudraMed)
  • Regular systematic literature monitoring


As per Regulation (EC) No 1223/2009 Cosmetovigilance concerns all cosmetic products placed on the market.

Indicative scope of services:


  • Responsible Person for cosmetic products
  • Collecting undesirable effects
  • Gathering the corresponding information on undesirable effects
  • Document, investigate, validate and evaluate undesirable cases within a context of prevention
  • Reporting on undesirable effects, serious undesirable effects and corrective measures
  • Implementation of corrective or preventive measures
  • Performing studies and preparing reports concerning the safety use of cosmetic products