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Post-marketing Pharmacovigilance

At Azierta, our team ensures that the management of Pharmacovigilance complies with all the requirements described in Best Practices of PV in the EU (GVP). 

We advise on:

  • The complete management and monitoring of spontaneous adverse reactions, including medical evaluation.
  • Bibliographic searches.
  • Safety Reports: PSUR, ACO, RMP, DSUR.
  • Design, registration, implementation, and maintenance of the Pharmacovigilance System Master File (PSMF).
  • Signal detection.
  • Local contact for Pharmacovigilance.
  • 24/7/365 contact for Pharmacovigilance.
  • Medical Device Vigilance.

We can also provide support in all post-marketing pharmacovigilance activities outside the EU.

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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