Pharmacovigilance

Cyton can ensure that you are in compliance with the latest pharmacovigilance (PV) guidelines. From catching up with a backlog of Periodic Safety Update Reports (PSURs) to outsourcing the entire PV responsibility, our dedicated team can tailor services to meet every need. Even if it is just to cover a period of staff absence or training, we are here to help.

Tailored Pharmacovigilance Services

Cyton’s PV team, supported by our Quality Assurance team and in-house veterinarians, can provide PV services tailored to your needs:

  • PSUR preparation and submission
  • Independent systems audit and inspection preparation
  • Electronic reporting and EudraVigilance support
  • In-house staff training
  • Fully outsourced PV system, including provision of the EU Qualified Person for PV (QPPV)
  • Preparation or critical review of the Detailed Description of the PV System (DDPS)

Inspection Readiness

In our role providing the services of the QPPV for our clients, Cyton’s PV team has been inspected by both National Competent Authorities (NCAs) and the European Medicines Agency (EMA), giving Cyton an intimate, practical knowledge of the regulatory requirements for PV systems. This gives Cyton the necessary expertise to provide pragmatic solutions to meeting the increasing regulatory burden of EU PV legislation.