Pharmacovigilance - safety first
Pharmacovigilance which is strictly regulated by European and local law require professional and individual approach. All services are provided by doctors and trained personal.
We offer individual services or outsourcing of whole pharmacovigilance:
- QP or EU QPPV services – Pharmacovigilance system design, maintenance and strategy, contact with Drug Regulatory Authorities (DRAs) across European Economic Area
- Local literature review - CZ, SK, PL, LIT, LAT, EST - more than 200 journals
- Monitoring of medical databases - Medline, Embase, Derwent Drug File and others
- Expedited reporting (CIOMS I, Eudravigilance) – ADRs collection, assessment, MEDDRA coding, evaluation, reporting, archiving
- PSURs writing - Periodic Safety Update Report
- Consultation before audit of pharmacovigilance
- ADRs from literature - ADRs collection, assessment, MEDDRA coding, evaluation, reporting, archiving
- Risk-Benefit evaluation
- PHV part of registration documentation:
1.8.1. Detailed description of pharmacovigilance system
1.8.2. Risk management plan
- PHV SOPs (Standard Operating Procedures) preparation
- Company staff training in pharmacovigilance
- Signal Detection / Safety Surveillance
- Provision of Full Pharmacovigilance Services for Clinical Trials
- Reply to Deficiency Letters concerning PHV sent by DRAs
Local literature review is provided in Czech Republic, Slovakia, Poland, Lithuania, Latvia and Estonia. We review more than 50 journals in Czech Republic, 40 in Slovakia, more than 80 journals in Poland, and about 30 in Baltic countries. The most of them are not indexed in literature databases like Medline, Embase or IMS, so our service is unique and more than 50 companies use it.
If you are interested in detail information or price offer, please contact us by email on This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
Are you also interested in expert report, patents or marketing support?