Getting Medicines to Market Faster

Pharmacovigilance Service Providers

Pharmacovigilance service provider of choice

Pharmacovigilance - Service providers

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:

  • Database migration from old to new can be problematic
  • QPPv and system changes are costly in terms of variations to MAs
  • Valuable in house resource needed to make the changes
  • Loss of face by getting it wrong

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?  

  • Do they have complaint and transparent processes?

Are they flexible?

  • Can they scale up quickly if the need arises?
  • Can they respond to changing legislation rapidly?

Is their pricing structure transparent?

  • Don’t get taken in with low upfront costs only to find heavily loaded case processing costs and hidden extras

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

For a full list see PV  A-Z 

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