CSO Pharma supports you to fulfil your Pharmacovigilance obligations as Marketing Authorisation Holder as legally required and requested. In doing so, we offer our services likewise as hands-on partner and reliable external support.
We develop and implement Pharmacovigilance (PV) processes and systems - according to current regulatory requirements and your needs. We support also small and medium sized enterprises to realize their own Pharmacovigilance system and give advice for improvement and harmonisation.
We also assume responsibility and act on behalf of the client as local QPPV according to the German Drug Law (Stufenplanbeauftragter) or as Qualified Person for Pharmacovigilance, QPPV.
Please feel free to contact us. We are looking forward to give you all the strategic and operational support you require.