Organised the way a product moves: approval, market entry, reimbursement, and lifecycle management.
Getting a healthcare product legally onto the Kenyan market, and keeping the quality systems behind it inspection-ready.
Registration pathway selection, classification, gap analysis against Pharmacy and Poisons Board requirements, and a filing plan with realistic timelines.
A filing strategy and dossier gap register.
Dossier compilation, eCTD publishing, agency correspondence, and management of queries through to determination.
A submission-ready dossier and a query log with closure evidence.
Quality management systems, SOP development, GxP readiness, and inspection preparation.
An SOP set, an audit-readiness assessment, and a remediation plan.
Taking a registered product into additional markets without rebuilding the dossier each time.
Harmonised submissions for EAC and wider African markets, with local adaptation where each authority requires it.
Pathways for products that do not fit standard routes: rare disease treatments, biologics, and advanced therapies.
Health product assessment and national benefit listing, from HTA dossier development to structured engagement with SHA and the panel secretariat.
Explore reimbursementAssembling the evidence a health technology assessment requires: clinical effectiveness against an appropriate local comparator, safety, and the value case in a form assessors can evaluate.
Incremental cost-effectiveness analysis using Kenyan cost and epidemiological inputs, and a budget-impact model against the relevant fund.
Structured engagement with the Ministry of Health, the Social Health Authority and the panel secretariat, sequenced so evidence arrives when it can be considered.
Sustaining a product's value after approval.
Variations, renewals, pharmacovigilance obligations, and commitment tracking.
Evidence assembly and submissions to broaden an approved indication.