What to look for in a Pharmacovigilance Consultant
The decision to use a pharmacovigilance service provider is not to be taken lightly, as once outsourced it is costly (and requires considerable effort) to change providers because:
Before committing – these are some of the things you should consider:
Do they provide all that we need (now and later on)?
Are they operating a high quality system?
Have they failed any inspections MHRA 2012 PV inspection report shows 19 critical findings across all pharma types?
Are they flexible?
Is their pricing structure transparent?
How does CambReg measure up?
We have been providing Pharmacovigilance Services and acting as the Medical information Department for a variety of companies since 2009 and are confident that we will ‘measure up’.
This is the place on our website where we could bore you ridged and possibly turn you away by giving you a very long list of all that we offer but as it’s not about us ‘suffice to say’ that we can provide what you need to fully outsource your pharmacovigilance function. If you do not need to outsource everything we are happy to offer any part of the service you need e.g. EU QPPv
System set up: Provision of client–tailored SOPs, PSMF, SPS, Eudravigilance and XEVMPD registration
Routine Pharmacovigilance activity: Provision of in house QPPV/Deputy QPPV/Medical expert oversight. Local QPs and Local Safety officers. Literature searching, Monitoring of Health Authority PV databases, Case processing (using propriety database) and reporting, signal detection and routine auditing.
Additional activities: Compilation of Risk Management Plans, PSURs etc
Cambridge Regulatory Services – Your Pharmacovigilance Service Provider of choice
Call 01480 465755 for a free estimate