Questions, answered straight.

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.

Yes. We run parallel filings across your priority markets under one coordinated strategy, rather than sequentially, so you’re not waiting years to reach your full target footprint.

Because a PV gap is one of the fastest ways to lose a hard-won authorization. Many African NRAs now require a functioning PV system, a local PV contact, and timely reporting as a condition of registration and renewal.

In many African markets, yes — you need a local Marketing Authorization Holder, a registered local agent, or an in-country responsible person to submit at all. Where required, ProReg can serve as your local representative.

It depends on scope — the number of countries, product type, and services needed. After a market-entry assessment we provide a clear, itemized scope and estimate, including regulatory fees, with no surprises.

No credible partner can guarantee a regulator’s decision. What we can do is maximize your probability of first-time approval and minimize avoidable delay — which is where most lost time and money actually sit.

No — a licence isn’t sales. A product still has to be priced, listed, reimbursed, and aligned to the procurement cycles that govern how medicines are bought in Africa. Our Market Access line turns authorization into revenue, including tenders, pricing, and donor mechanisms such as Gavi and the Global Fund.

A growing number of authorities expect local or regional clinical evidence before granting or extending approval. We manage the ethics and regulatory pathway, IMP import permits, and GCP readiness so the evidence your dossier needs is generated cleanly, on time, and accepted.

Yes. ProReg Academy trains regulatory affairs, pharmacovigilance, quality, and market-access teams through short courses, structured certificate programs, and custom in-house training built around your products and target markets — delivered by the practitioners who file the dossiers every day.