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EU Qualified Person Responsible For Pharmacovigilance

We assist small to large pharmaceutical companies all over the world to keep medicines, vaccines, and devices safe for users. We also support companies to stay compliant with regional and national regulations.

Amongst our services we include:

  • Artificial Intelligence support in pharmacovigilance
  • EU Qualified Person Responsible For Pharmacovigilance (QPPV)
  • National Local Contact for Pharmacovigilance
  • Medical Reviews Of Adverse Events
  • Medical Monitoring Of Clinical Trials
  • Signal & Risk Management
  • Periodic Safety Update Reports (PSUR)
  • Drug Safety Update Reports (DSUR)
  • Risk Management Plans (RMP)
  • EudraVigilance
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Professional Consulting Services

We have expert medical staff with decades of have combined experience in pharmacovigilance for both the US and EU markets. We provide support for all aspects of the QPPV responsibilities at EU level and at individual member state level.

These are including but not limited to:

  • Establishing and maintaining a pharmacovigilance system.
  • Preparing pharmacovigilance reports as defined by regulations.
  • Answering requests from Health Authorities.
  • Having an overview of the safety profiles and any emerging safety concerns for the company’s drugs.
  • Acting as a single contact point for the Health Authorities on a 24-hour basis.
  • Artificial Intelligence (AI) support for generation adverse event lay descriptions for informed consent
  • AI support for signal analysis and comparative reviews
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