Product vigilance

file folder with documents and documents

  • Prescription drugs
  • Over-the-counter drugs (OTC)
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Vigilance of Medical devices
  • Medical devices (Type I, IIa, IIb in III)
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  • Cosmetics
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We are experts and have in-depth knowledge in the area of Product vigilance (Pharmacovigilance, Vigilance of Medical devices, Cosmetovigilance).
We can be your local (EU) representative for Product vigilance.

We offer following services:


Setting up of  Product Vigilance System:

  • review of existing legislation,
  • preparation of Standard Operating Procedure for Product Vigilance System (Pharmacovigilance/Vigilance of Medical devices) in accordance with currently valid legislation,
  • appointment of Responsible person for Product Vigilance System  in accordance with currently valid legislation at respective Ministry of Health/Agency for Medicines,
  • communication and coordination with EU Ministries of Health,
  • connection of your internal Product Vigilance System with the Product Vigilance System of Quantum Chimica Ltd.,
  • preparation of Standard Operating Procedures for activities necessary  for monitoring and reporting of side effects, Education, Literature review and for other activities (preparation of Risk Management Plan, Activities necessary for pre/post marketing studies and for submitting of Safety variations).

 Implementation of Product Vigilance System:

  • regular reporting to EU Ministries of Health and 24/7 availability of Responsible person,
  • active participation during the Audit from respective Ministries of Health, Third Party Companies, etc.,
  • review of the relevant literature,
  • management and maintenance of documentation,
  • training of employees in the area of Product Vigilance.