We are delighted welcoming you to the website of ‘SCRATCH Pharmacovigilance GmbH & Co KG’.
We offer our customers a wide range and customised services in the field of safety of
- (human/veterinary) medicinal products
- medical devices
- Blood and tissue preparations
We support you in questions of safety/pharmacovigilance in clinical trials, in the authorisation process and after authorisation, be it through
- Long-term takeover of entire processes or selective support in the event of shortfalls
- Taking over functional positions such as QPPV or graduated plan officer or simple preparatory work
- Auditing your safety-relevant processes or training your employees.
Together with you, we will find exactly the service you need.
If you have any further questions, you are welcome to contact us at contact@scratch-pv.com.
The PV System and its PSMF are essential obligations for any EU Marketing Authorisation Holder.
The QPPV plays THE leading role in EU PV – similar to the Graduated Plan Officer in Germany.
Not optional, not easy to implement: PV Compliance has turned into a continuous burner.
The ’if’ of PV system audits (including all its components) has been answered (yes); the ‘how’ however remains a difficult topic for many of those responsible.
RMPs are needed for nearly every new EU drug marketing authorisation. They are also due with every PV relevant variation. But how do you bring cost efficiency and compliance together?
‘Aggregate Reports’ are about product overview, about a current evaluation of the safety profile and the benefit / risk ratio.
The development of effective, meaningful, and sustainable PVAs is one essential way of dealing with the complexities of a PV system.
PV data from clinical studies are of particular importance for safety profile evaluation: Nowhere else are data of this quality available.
Managing Drug Safety Monitoring Boards, Pharmacovigilance training, Management Coaching, Strategic PV Consultancy and much, much more.