Pharmacovigilance & Safety
The safety systems that keep your licence alive
A pharmacovigilance gap is one of the fastest ways to lose a hard-won authorization. We close that gap.
What we do
How this service works
In a growing number of African markets, a functioning PV system, a local PV contact, and timely safety reporting aren't optional extras — they're a condition of registration and renewal. Get them wrong and the licence you fought for can be refused, suspended, or revoked.
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01
PV system set-up
local PV system master file, procedures, and infrastructure tailored to each market
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02
Local QPPV / PV contact services
providing the in-country responsible person many NRAs require
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03
Adverse event management
collection, processing, and expedited reporting to national authorities
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04
Periodic reporting
PSURs / PBRERs prepared and submitted on schedule
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05
Signal detection & risk management
ongoing benefit-risk monitoring, RMPs, and risk-minimization measures
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06
Audit & inspection readiness
preparing your system to pass NRA inspection
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07
Training & capacity building
equipping your local teams and partners
Ready to move on Pharmacovigilance & Safety?
Tell us your product and target markets — we'll map the fastest compliant path.