Services
Pharmacovigilance that stands up to inspection
A complete safety system for marketing authorisation holders in Kenya and East Africa: the people, documents and routines regulators expect to see working every day.
What’s included
Qualified person for pharmacovigilance (QPPV)
A qualified person responsible for the safety of your products in Kenya, with a named deputy, available to the regulator.
Adverse event reporting
Receiving, assessing and reporting adverse events to the Pharmacy and Poisons Board on time.
Periodic safety reports
Periodic safety update reports written, reviewed and submitted on schedule.
Safety signal management
Detection, validation and follow-through with documented decisions.
Pharmacovigilance system master file
The master file that describes your safety system as it really runs.
Medical literature monitoring
Global and local medical literature checked for safety information and logged.
Risk management plans
RMPs and risk minimisation measures adapted to local practice.
What you receive
- A gap report against current regulator expectations
- SOP set and PSMF tailored to your products
- Named QPPV and backup with contact routines
- Monthly compliance summary for leadership
- Inspection support on the day
How it runs
- Discovery and gap assessment Starting point
- System build: SOPs, PSMF, database Sized to your portfolio
- Team training and go-live Before you go live
- Ongoing operation and oversight Monthly reporting
Pharmacovigilance FAQ
Yes. The Pharmacy and Poisons Board expects every marketing authorisation holder to name a qualified person responsible for pharmacovigilance who can be reached in Kenya. We can act as that person, or back up and train yours.
Yes. We plan a handover so no case or report deadline is missed.
National regulator requirements first, aligned with ICH E2 guidance and WHO good pharmacovigilance practice.