Pharmacovigilance
A named qualified person for pharmacovigilance, adverse event reporting to the Pharmacy and Poisons Board, periodic safety reports and safety signal management.
Pharmacovigilance & Regulatory Affairs · East Africa
Safer medicines. Faster approvals. Inspection-ready, every day.
We help pharmaceutical, medical device and health product companies register products, run compliant pharmacovigilance systems and stay ready for regulators across Kenya and the region.
PPB Kenya · NDA Uganda · TMDA Tanzania · Rwanda FDA · EFDA Ethiopia
Book a consultation
Step 1 of 4Pick a session. Times shown in EAT.
Discovery call30 min · Video · Confirms instantly
Regulatory strategy session60 min · Video
PV system review60 min · Video
Next available
Mon 08:30
Mon 09:00
Mon 09:30
Mon 10:00
Continue
Start where you are
Where is your product or PV system right now?
Entering the Kenyan or East African market
Registration strategy, CTD dossiers and a Local Technical Representative. Start here
An inspection is announced or expected
Readiness assessment, mock inspection and gap closure before the regulator arrives. Start here
You need a QPPV or local safety person
Qualified people for pharmacovigilance, case processing and safety reporting. Start here
Building a PV system from scratch
PSMF, SOPs, safety database set-up and team training that holds up to scrutiny. Start here
What we do
One partner for safety, registration and compliance
Regulatory Affairs
Product registration with the Pharmacy and Poisons Board and other East African regulators, dossiers, variations, renewals and local representation.
Quality & Compliance
Pharmacovigilance audits, inspection readiness and written procedures that reflect how your team really works.
Medical Information
A medical information service that answers questions about your products and captures adverse events.
Training
Pharmacovigilance and regulatory affairs training for your staff, online or at your premises.
Market Access & Advisory
Advice on entering the Kenyan and East African markets and keeping up with regulatory changes.
Across the product lifecycle
With you from dossier to decades of safe use
One team carries your product through every stage, so knowledge is never lost between a registration consultant, a safety vendor and an auditor.
- Develop and register: regulatory strategy, CTD dossiers, LTR
- Launch: PV system, PSMF, QPPV in place before first sale
- Monitor and renew: case processing, PSURs, signals, variations, renewals
How we work
From first call to inspection-ready, in four steps
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Step 1
Discovery call
A free 30-minute call to understand your products, markets and deadlines.
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Step 2
Gap assessment
We review your dossiers or PV system against current regulator expectations.
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Step 3
Plan and proposal
A clear scope, timeline and owners, so everyone knows what happens next.
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Step 4
Delivery and oversight
We deliver, report and stay on as your safety and regulatory partner.
Who we help
Built for companies that answer to regulators
Based in Eldoret, working with the regulators of Kenya, Uganda, Tanzania, Rwanda and Ethiopia.
Manufacturers
Local and international manufacturers registering human medicines and health products.
Importers and distributors
Marketing authorisation holders who need a QPPV and a working pharmacovigilance system.
Medical device companies
Registration and post-market vigilance for medical devices and diagnostics.
Herbal and complementary
Registration and safety obligations for herbal and complementary products.
Yes. Many clients are manufacturers abroad entering Kenya and East Africa. Where a regulator requires a local representative, we can act as your Local Technical Representative.
A free 30-minute video call to understand your products, markets and deadlines. You leave with clear next steps, whether or not you work with us.
Yes. We provide qualified people for pharmacovigilance and run case processing, safety reporting and PSMF upkeep for you.
We work under NDA, limit access to the people on your project and handle personal data in line with the Kenya Data Protection Act 2019.
Yes. We run pharmacovigilance and regulatory affairs training online or at your premises, tailored to your products and markets.
Talk to a regulatory expert this week.
A free 30-minute discovery call. No obligation, clear next steps.