Global Pharmacovigilance

In Europe

PSURs must be renewed as often and following the reference dates published by the European Medicines Agency (EMA).

In the USA

The Federal Drug Administration (FDA) requires the management of PSURs.

We can prepare your reports ready for submission. We have extensive experience in preparing high quality PSURs to ensure compliance with requirements.

Business Cases

  • Case Study detail

    Local Pharmacovigilance Management

    Global Pharma Company, United States
  • Case Study detail

    Full outsourced EU Pharmacovigilance system

    Leading Generic company, North America

Contact Us

If you want to dicuss how you can be safe in our hands, please contact us for a consultation.

Telephone: +353 125 44033

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