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)
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.
Post Brexit EU QPPV for the Animal Health Industry
The UK's decision to leave the EU has caused much uncertainty, but it has become clear that marketing authorisation holders for veterinary medicines must have a QPPV who resides in the EU. As such, any company with a QPPV resident in the UK will be obliged to identify a new QPPV who is resident in a different EU member state from March 2019.
With the establishment of Cyton's German office (see www.cyton.com/germany), Cyton will continue to provide an EU based PV system and QPPV, post Brexit. Any of our clients can benefit from this by naming Cyton as their third party PV service provider.