Our Qualified Person and all Pharmacovigilance team are ready to meet you and solve all legislative requirements required on your PhV system. We can offer our own validated safety database, electronic reporting to Eudravigilance, preparing Standard Operating Procedures and agreements about safety data exchange between you and your partners, assistance or preparing of risk management plans (RMPs), responding to regulatory enquiries, helping with evaluation of benefit and risk and assisting in responding to safety concerns. And last but not least, we also provide your staff with training and prepare you for planned audits.
The main goal of our work is security. Monitoring, reporting and evaluation of side effects of drugs that may occur during treatment are to prevent potential risks, protect the patients, the physicians and the medicinal products. Our vigilance support covers full 24/7/365 assistance service according to local/EU requirements and is tailored based on client needs.
The same emphasis on product safety is increasingly being given to other areas of health and fitness of each and every one of us. That is why surveillance of the safety of goods on the market also applies to other groups of products in the field of medical devices, food supplements and cosmetics.
Pharmacovigilance for a human medicinal/veterinary products
- Establishing PhV system
- Set-up of entire PhV system – PSMF/DDPS, SOPs
- Full PhV responsibility
- PhV system maintenance
- 24/7/365 service for AE/AR reporting
- PhV database
- Literature search service
- Safety studies /clinical trials support
- Complex services of EU QPPV
- local contact person for CZ/SK authorities
- EudraVigilance Support (including XEVMPD, EVDAS)
- Regular PhV training of the stuff
Vigilance for other areas
- Safety surveillance services for all classes of medical devices, cosmetics products and food supplements
- Processing, handling and reporting of (Near)Incidents between a manufacturer and relevant authority
- Quality complaints