Services
Consulting services in pharmacovigilance for the Pharmaceutical industry. From local partner functions to global activities.
-
Local Contact Person for Pharmacovigilance (LCPPV) in Spain and Portugal (Iberia)
-
Local Literature Monitoring (LLM, LLS)
-
Regulatory Intelligence
-
GVP Audits
-
ICSR Management
-
MIE Management
-
Adaptation of Educational Materials for aRMM, Risk Management Plan (RMP)
-
Pharmacovigilance trainings
-
Deviation and CAPA management
-
Audit and inspection readiness
-
Pharmacovigilance training
Pharmacovigilance consultancy
SOP Development
An essential element of any pharmacovigilance system is that there are clear written procedures in place. GVP Module I describes the required minimum set of written procedures for pharmacovigilance.
We can support you in their development or improvement.
Key Performance Indicators (KPI)
A list of performance indicators must be provided in the Annex to the PSMF, alongside the results of actual performance measurements.
We can help you in developing a set of key performance indicators.
Compliance Monitoring and vendor oversight
Where a marketing authorisation holder has subcontracted pharmacovigilance tasks, it shall retain responsibility for ensuring that an effective quality system is applied.
We provide services in vendor and compliance oversight.
Deviation and CAPA mangement
Corrective and preventive measures should be implemented when deemed necessary. In particular as a consequence of audits, corrective action(s), including a follow-up audit of deficiencies, shall be taken where necessary.
Audit and Inspection readiness
Processes to monitor the performance and effectiveness of a pharmacovigilance system and its quality system should include audits. Regular audit of the PV system is a mandatory requirement.
We peform GVP Audit to ensure yuor PV system is compliant with regulations.
PV Training
Achieving the required quality for the conduct of pharmacovigilance processes by an organisation is intrinsically linked with the availability of competent and appropriately qualified and trained personnel. All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training.