Services / Regulatory Affairs & Pharmacovigilance

Regulatory Affairs & Pharmacovigilance

Nowadays, complying with the strict and complex Regulatory framework is a challenge for every organisation. In addition, Pharmacovigilance obligations have increased over the years, while the national requirements have become a challenge for companies that wish to penetrate the Cyprus market. Our experienced personnel can service your needs by providing cost-effective solutions. Amongst others we can offer the following services:

  • Registration for Pharmaceuticals, Food Supplements and Medical Devices
  • Post marketing Regulatory activities
  • Appoint a local Qualified Person Responsible for Pharmacovigilance (QPPV) and Deputy
  • Prepare and submit a local Pharmacovigilance System Master File (PSMF)
  • Local literature review
  • Pharmacovigilance training for your personnel
  • Case Report Management – 24h availability
  • Recall responsibility
  • Risk Management Plan (RMP) preparation and submission
  • Inspection and Audit Readiness

For additional information, please contact: services@gpetrou.com.cy or call +357 22757277