Services
Organised the way a product moves: approval, market entry, reimbursement, and lifecycle management.
Approval
Getting a healthcare product legally onto the Kenyan market, and keeping the quality systems behind it inspection-ready.
Regulatory strategy
Registration pathway selection, classification, gap analysis against Pharmacy and Poisons Board requirements, and a filing plan with realistic timelines.
ProducesA filing strategy and dossier gap register.
Submissions and eCTD
Dossier compilation, eCTD publishing, agency correspondence, and management of queries through to determination.
ProducesA submission-ready dossier and a query log with closure evidence.
Compliance and quality
Quality management systems, SOP development, GxP readiness, and inspection preparation.
ProducesAn SOP set, an audit-readiness assessment, and a remediation plan.
Market entry
Taking a registered product into additional markets without rebuilding the dossier each time.
Multi-market dossiers
Harmonised submissions for EAC and wider African markets, with local adaptation where each authority requires it.
Specialised therapeutics
Pathways for products that do not fit standard routes: rare disease treatments, biologics, and advanced therapies.
Reimbursement
Health product assessment and national benefit listing, from HTA dossier development to structured engagement with SHA and the panel secretariat.
Full detail on its own pageHTA dossier development
Assembling 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.
Cost-effectiveness and budget-impact modelling
Incremental cost-effectiveness analysis using Kenyan cost and epidemiological inputs, and a budget-impact model against the relevant fund.
Stakeholder engagement and SHA liaison
Structured engagement with the Ministry of Health, the Social Health Authority and the panel secretariat, sequenced so evidence arrives when it can be considered.
Lifecycle
Sustaining a product's value after approval.
Post-approval management
Variations, renewals, pharmacovigilance obligations, and commitment tracking.
Label and indication expansion
Evidence assembly and submissions to broaden an approved indication.