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: [email protected] or call +357 22757277