Shorter time to authorization
The right pathway chosen up front and a query-resistant dossier remove the months most companies lose to avoidable rework.
ProReg Africa — product registration, market access, pharmacovigilance and clinical trials across Africa.
Your trusted partner for product registration, pharmacovigilance, and regulatory compliance across Africa.
The barrier usually isn't your product — it's the registration. ProReg Africa gets pharmaceutical, biotech and medical-device products authorized, available and compliant across Africa.
One accountable partner
One strategy and one status view across every African market you target.
Reliance done properly
WHO PQ, WLA/SRA and collaborative procedures used wherever they cut months.
Your local presence
In-country MAH, agent or QPPV where the market requires one to even submit.
The Challenge
Your product is approved everywhere else. So why isn't it on the shelf in Africa?
For most pharmaceutical companies, Africa isn't a scientific problem — it's a registration problem. The product exists. The data exists. What stands between you and the market is a fragmented maze of submissions, queries, and country-by-country requirements.
The problem → what it costs you
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01
Registration drags 12–36 months
CostDeferred revenue, expired stock, missed tender cycles
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02
Dossiers bounce back on avoidable deficiencies
CostEach query round adds 3–6 months — most are preventable
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03
40+ markets, each different
CostA patchwork of local agents, no single view, no accountability
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04
Reliance pathways left on the table
CostYou redo work that WHO PQ, WLA, and collaborative procedures could fast-track
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05
No local MAH or in-country agent
CostYou can't even submit in markets that require local presence
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06
No compliant PV system in place
CostNRAs can refuse or revoke approval — the licence lapses on a technicality
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07
Local clinical data required but missing
CostApproval is delayed or denied until the evidence exists
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08
Approval lapses post-launch
CostMissed renewals and PV gaps suspend the licence you fought to win
Our Mission
We exist to put safe, quality-assured medicines within reach of every African patient — by making the path from approval to market the fastest, clearest part of your journey, not the hardest.
What We Do
Four service lines, one outcome.
Your product authorized, available, and protected across Africa — from first strategy to ongoing safety oversight.
01
Market Authorization & Regulatory Affairs
The fastest compliant route to registration across Africa
Explore → 02Market Access
From authorization to availability — so your approved product actually sells
Explore → 03Pharmacovigilance & Safety
The safety systems that keep your licence alive
Explore → 04Clinical Trials & Research Compliance
Inspection-ready studies, on time — turning local data into an asset
Explore →Why ProReg Africa
We don't just file dossiers. We get your product to market — and keep it there.
ProReg Africa exists to do one thing exceptionally well: turn your registration backlog into products on the shelf, faster and with fewer surprises — then protect the licence once it's won.
What sets us apart
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We compress time-to-market. We build the right submission strategy from day one — the correct pathway, a query-resistant dossier, and parallel filings across priority markets — so your product reaches patients in the shortest compliant time, not the longest.
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We get it right the first time. Most delays come from preventable deficiencies. Our dossiers are screened against each NRA's real expectations before they go in, cutting query rounds and the months they cost.
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We make reliance work for you. We know exactly where WHO Prequalification, WLA/SRA recognition, and collaborative procedures can accelerate approval — so you don't pay in time for work that's already been done.
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We are your single point of accountability. One team, one strategy, one status dashboard — across every market. No chasing scattered agents. When you ask "where is my registration," you get a straight answer.
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We can be your local presence. Where markets require an in-country Marketing Authorization Holder, agent, or local QPPV, we provide it — so the markets that were closed to you open up.
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We keep your licence alive through PV. Many African NRAs now require a functioning PV system, a local contact person, and timely safety reporting as a condition of registration and renewal. We build and run that system for you.
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We unlock markets that demand local data. A growing number of authorities expect local clinical evidence before they'll grant or extend approval. We make trials an asset, not a bottleneck.
40+
Markets
4
Service lines
1
Accountable team
Where We Work
Francophone and Anglophone Africa — one coordinated strategy.
We run parallel filings under a single plan across 40+ markets and own the outcome end-to-end — so you always know exactly where each submission is, and what happens next.
The bottom line
We are measured by one thing — your product, authorized and available in the shortest compliant time, and protected for the full life of its licence.
Our Approach
A structured path from strategy to a licence that lasts.
Four stages, one accountable team. Each one closes before the next begins, and you can see exactly where you stand at any point.
Step 1
Strategy & Country Prioritization
We map your product against every target market: which country first, which pathway in each, and the filing sequence that reaches revenue fastest. You leave with a dated roadmap, not a proposal.
Step 2
Dossier Build & Pre-Submission Screen
CTD/eCTD/ACTD structuring, CMC and labelling review, then a screen against each authority’s real expectations before anything is filed — which is where query rounds are won or lost.
Step 3
Submission & Query Management
We file in parallel across priority markets and drive every deficiency round to closure, using reliance and collaborative procedures wherever they can compress the timeline.
Step 4
Access, Safety & Lifecycle
Approval is half the job. We handle pricing, listing and tender alignment, run the pharmacovigilance system, and keep every variation and renewal current so the licence never lapses.
Key Benefits
Faster authorization. Fewer surprises. A licence that holds.
One accountable team, 40+ markets
One strategy and one status view replace a patchwork of local agents — so you always know where each submission stands and what happens next.
Markets that were closed, opened
Where a country requires a local Marketing Authorization Holder, agent or QPPV, we provide it — and where it requires local clinical data, we generate it.
A licence that stays in force
A compliant pharmacovigilance system, timely safety reporting and disciplined renewals protect the approval you fought to win, for its full life.
Reliance & harmonization pathways we navigate
- WHO PQ
- WLA / SRA
- WHO CRP
- ZaZiBoNa
- African Medicines Agency
- ECOWAS · WAHO
- UEMOA
- CEMAC · ECCAS
Questions, answered
The questions we hear most often.
A quick start on registration, reliance, pharmacovigilance, and what it takes to reach African patients.
We get pharmaceutical, biotech, and medical device products authorized, available, and compliant across West and Central Africa — and keep them there. In practice: regulatory strategy and registration, pharmacovigilance, and clinical trial compliance, managed by a single accountable team across every market you target.
We operate across West and Central Africa, with on-the-ground capability in markets including Nigeria, Ghana, Senegal, Côte d’Ivoire, Benin, and Cameroon, and coverage on request across the wider ECOWAS, UEMOA, CEMAC, and ECCAS regions.
Yes. Many of our clients enter the continent for the first time. We start from your product and target countries, design the fastest compliant pathway, and manage the entire process — including acting as your local presence where required.
It varies by country, product type, and pathway — indicatively 12 to 36 months for a new product through full assessment, and considerably less where reliance or collaborative procedures apply. The biggest variable is dossier quality.
Reliance means an authority recognizes work already done by a trusted reference — WHO Prequalification, a Stringent/WHO-Listed Authority approval, or a collaborative procedure — instead of repeating a full assessment. Used well, it can substantially shorten your timeline.
Ready to get your product on the African market?
Tell us your target countries and your product. We'll show you the fastest compliant path to authorization — and to patients.