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Pharmacovigilance

Stay in compliance with current legislation.

The EU pharmacovigilance legislation from July 2012 has implications for you as Marketing Authorisation Holder. At LINK Medical, you will find all the expertise you need. Our specialised consultants can guide you through the process and implement the Good Vigilance Practice for medicinal products for human use as well as the guidelines for medicinal products for veterinary use and medical devices. You will always get the solution that suits you best. You can choose to insource our consultants to your facility or outsource your assignment to be executed by our
in-house resources.

Services within pharmacovigilance:

  • Spontaneous and periodic reporting of adverse events
  • Electronic reporting (EudraVigilance, EudraVigilance Veterinary)
  • Registration of product information in  XEVMPD
  • Literature searches – local and worldwide
  • Medical coding (MedDRA, VedDRA)
  • Medical evaluation
  • Pharmacovigilance System Master File (PSMF)
  • Risk Management Plan (RMP)
  • Standard Operating Procedures (SOPs)
  • Signal detection and evaluation
  • Training

Get the full advantage of our experience in national and international drug safety reporting in clinical trials and post-marketing, as well as in writing and maintenance of the Pharmacovigilance System Master File (PSMF). You can count on us all the way from receipt of initial data to regulatory reporting. Our safety officers are certified users of the EudraVigilance web-based reporting tool (EVWEB).

Contact us for more information about Pharmacovigilance services.

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