African regulatory expertise.
Four integrated capabilities that cover the full regulatory lifecycle — from first-market strategy to continental registration and ongoing compliance. Built on 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, market authorisation support, 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.
We partner with leading global health institutions, development finance partners, philanthropic organisations, national regulatory authorities, pharmaceutical and medical device manufacturers, and biotech and digital health companies.
For us, regulatory affairs is not just a compliance exercise. It is the difference between access and delay.
This breadth of engagement gives us something few organisations can claim: a systems-level understanding of how regulatory policy, innovation, commercial strategy, and patient access intersect across Africa’s most important markets.
Four capabilities.
One integrated practice.
Regulatory affairs, anchored in Africa.
Shaami draws on a multi-disciplinary bench of in-house experts, trusted consultants, and partner organisations, giving every engagement more expertise to call on than any single firm could offer alone.
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, market dynamics, and the political economy that shapes them.
African by design
Deep knowledge of African regulatory environments, while being fluent in global best practice. We shape strategies that are practical as well as 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 to post-market obligations — no fragmented relationships across the continent.
Systems-level perspective
We work with both NRAs and manufacturers, so we have insight into both sides of every submission. That dual vantage shapes how we advise on policy 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.
Ready to discuss your regulatory needs?
Our team responds within five business days with a clear pathway and fee proposal.