Pharmacovigilance

We understand the importance of the pharmacovigilance requirements for your product. Our experienced staff (including an in-house physician) are committed to on-time, high quality service. We can help you in your pharmacovigilance activities by offering a full range of services:

  • Provision of EEA QPPV and deputies
  • RMPs, PSURs, PSMFs, DSURs (advice and writing)
  • Electronic reporting of SUSARs and ADRs to EMA and European Competent Authorities (clinical trials and post-marketing cases)
  • Performing literature searches
  • Preparation of client-tailored pharmacovigilance SOPs
  • XEVMPD support

We have a validated ICH E2B compliant database to assist in the reporting activities.

Interested in our service? Let's talk