Pharmacovigilance
Pharmacovigilance
We offer Pharmacovigilance services in compliance with the Guideline on good pharmacovigilance practices (GVP):
Provision of full Pharmacovigilance System and dossier documentation
- Pharmacovigilance project management
- Pharmacovigilance System Master File (PSMF)
- PSMF summary (Module 1.8.1)
- Qualified person for PV in Europe (EU QPPV), Deputy QPPV and local QP representatives in each European country
- Risk Management Plans (RMP) (Module 1.8.2)
Eudravigilance registration/support
- Extended Medicinal Product Dictionary (XEVMPD) submission
- Literature searches and database consulting (global and local)
- PSURs submissions
- MLM monitoring
- Eudravigilance reporting
- Signal detection
Safety Reports
- Post-marketing case processing management
- Periodic Safety Updates Reports (PSUR)
- Individual case safety report (ICSR) processing and follow-up. Collection, medical review, quality check, submission, documentation and archiving
- Expedite reporting in accordance with regulatory requirements
- Setup of electronic reporting with EU NCAs (preparation of cases and full testing)
- Safety database management
Standard operating procedures (SOPs)
- Set of written instructions to document your Pharmacovigilance activities
Audits
- Good pharmacovigilance practice auditing
Please, send safety information or reports of adverse events via email at: safety@altiex.com
Because we are aware about the importance of Pharmacovigilance in the public health, we want to help you in monitoring the safety of your medicines anywhere in the world.
Registered Office
- Nám. 14. října 2/1307
- 150 00 Praha 5
Czech Republic - Tel: +420 222 351 874
- Fax: +420 222 351 875
- info@altiex.com
