Regulatory expertise,
built for Africa.
Four integrated capabilities that cover the full regulatory lifecycle — from first-market strategy to continental registration and ongoing compliance. Informed by lived experience of African regulatory environments and global best practice standards.
Shaami is the regulatory practice of Market Access Africa.
We bring together regulatory consulting, in-country representation, compliance readiness, regulatory intelligence, and systems strengthening under one roof — serving manufacturers, national regulatory authorities, regional bodies, and global health institutions across the African continent.
Our work spans collaborations with leading global health institutions, development finance partners, philanthropic organisations, national regulatory authorities, pharmaceutical and medical device manufacturers, and emerging biotech and digital health companies. We don’t view regulatory affairs as a compliance exercise. We treat it as the strategic lever that determines whether a product reaches the patients who need it — and how fast.
This breadth of engagement gives us something few firms can claim: a systems-level understanding of how regulatory policy, innovation, commercial strategy, and patient access intersect across Africa’s most consequential markets. We use that understanding to deliver transformative outcomes — not just for individual product pathways, but for the health ecosystem itself.
Four capabilities.
One integrated practice.
A practice is the people who do the work.
Shaami works through a deliberate mix of in-house experts, trusted consultants, and partner organisations across the continent. We don’t pretend to know everything — we make sure the right person, and the right institution, is on every engagement.
Beyond our own bench, an institutional network across the continent.
Shaami partners with specialist agencies and consultancies to extend our reach — clinical research organisations, regulatory consultancies, and academic institutes whose work complements ours.
Each engagement is structured to match the specific regulatory work and the right institutional capability.
Built for this. Only for this.
Shaami is not a global consultancy with an Africa practice. It is an Africa practice — built from within, by people with lived experience of African health systems, regulatory bodies, and the political terrain that shapes them.
African by design
Deep knowledge of African regulatory environments, fluent in global best practice. We shape strategies that are practical, not just compliant.
Intelligence-led
The Shaami Spotlight tracks every regulatory development across all 55 African markets. Our clients see what’s changing before official announcements reach the market.
Full lifecycle coverage
One partner from feasibility through post-market obligations. No coordinating fifteen LTRs, no fragmented relationships across the continent.
Systems-level perspective
We work with NRAs and manufacturers — both sides of every submission. That dual vantage shapes how we advise on policy, innovation, and market access.
Diagnostic & digital focus
Deep expertise in SaMD, IVDs, and digital health — Africa’s fastest-growing registration categories, and the ones traditional pharma consultancies are least equipped to handle.
Swiss-backed structure
Market Access Africa, Swiss-registered, provides the commercial and liability framework. In-country entities provide the regulatory presence and accountability.
Ready to discuss your regulatory needs?
Our team responds within five business days with a clear pathway and fee proposal.