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Industrial Area

Pharmacovigilance & Safety

As a leading consultant in the field of science and health, at Azierta we have extensive experience in pharmacovigilance and we are adapted to the latest legislative requirements.  

With the launch of the latest version of Eudravigilance, a new scenario has emerged in pharmacovigilance, which implies significant changes to ensure regulatory compliance and effective management of pharmacovigilance on a daily basis.  

Therefore, thanks to our team of experts we design innovative and cost-effective solutions to help our clients adapt quickly to this new environment.  

In Azierta we are experts in pharmacovigilance and we are 100% aligned with the current European pharmacovigilance environment.

We offer integral services at an international level, ranging from early development, through registration, to the marketing and post-marketing phases of your product, implementing personalized solutions totally adapted to the client's needs, also counting on our own database Vigilazierta: Database Solution.    

Our team ensures that the management of Pharmacovigilance meets all requirements described in the EU Good PV Practices (GVPs) including.The complete management and monitoring of spontaneous adverse reactions, including medical evaluation:  

  • Literature searches  
  • Security reports: PSUR, ACO, RMP, DSUR.  
  • Signal detection.  
  • Design, registration, implementation and maintenance of the Pharmacovigilance System Master File (PSMF).  
  • Local contact for Pharmacovigilance.  
  • 24/7/365 contact for Pharmacovigilance.  
  • Healthcare products surveillance.  

Extensive information about our services:

  • Pharmacovigilance in clinical trials  
  • Post-marketing pharmacovigilance:  
RAM monitoring
RAM monitoring
Security Reports
Security Reports
Remote or on-site audits
Remote or on-site audits
European and local QPPV support
European and local QPPV support
Outsourcing
Outsourcing

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

We are at your complete disposal for any inquiry

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