Regulatory intelligence for Africa.
Field-tested perspectives from our team on the evolving regulatory landscape across the continent — free to read, share, and reference.
Why the African Medicines Regulatory Authority (AMA) Changes Everything for Pharma Strategy in 2025
The African Medicines Regulatory Authority became operational this year, ushering in a continent-wide framework that will reshape how marketing authorizations are pursued across the 55 AU member states. We examine what this means for product launch timelines and where the transitional windows remain.
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Preparing for WHO PQ Inspections: A Practical Audit Checklist for East African Manufacturers
WHO Prequalification audits remain the gold standard for accessing donor-funded tenders across EAC and SADC markets. Drawing from recent inspection experiences across Kenya, Tanzania and Uganda, our team breaks down the 14 most common deficiencies and how to address them before the inspector arrives.
Building a PV System That Scales: Lessons from Multi-Country Rollouts Across ECOWAS
Pharmacovigilance obligations vary widely between Nigeria’s NAFDAC, Ghana’s FDA and the Francophone regulators. We map the practical differences, the shared reporting templates that work everywhere, and how to staff a PV hub that serves the entire West African region without duplicating effort.
Pharmacovigilance in Practice: From Case Receipt to Regulatory Reporting
How an adverse event moves through intake, coding, medical review and submission, and where local safety teams most often lose time.
What a Complete Dossier Looks Like: CTD, eCTD and Local Formats
A practical walk through dossier compilation, and why gap analysis before submission saves months with African authorities.
Regulatory Intelligence: Turning Policy Change into Market-Entry Strategy
Why landscape mapping and forecasting belong at the start of an Africa launch plan, not after the first rejection.
Medical Writing That Survives Review: CSRs, IBs and Summary Documents
The structure and QC steps that keep regulatory documents clear, consistent and aligned with current guidelines.
Labeling Across Markets: Harmonising Without Losing Local Compliance
How to run translation, artwork review and proofreading as one workflow instead of six separate approvals.
Preparing for a GMP Inspection: Gap Assessment to Verification
A five-stage approach to audit readiness, remediation planning and sustaining a culture of quality.
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