Start with the stage your product is at. We can help you work through the requirements and agree what needs to happen next.
We help you prepare for registration in Kenya and keep the supporting quality systems ready for inspection.
We check how your product is classified, review the dossier against Pharmacy and Poisons Board requirements and agree a filing plan based on the work still needed.
A filing strategy and dossier gap register.
We assemble the dossier, publish eCTD submissions and handle correspondence and queries while the authority reviews the file.
A submission-ready dossier and a query log with closure evidence.
We help your team document procedures, review GxP readiness and prepare the quality systems for inspection.
An SOP set, an audit-readiness assessment, and a remediation plan.
Planning another market? We adapt your existing dossier to local requirements so you can reuse the work you have already done.
We prepare harmonised submissions for EAC and wider African markets, then adapt the file to the requirements of each authority.
Some products need a different approach. We help identify the route for rare disease treatments, biologics and advanced therapies.
We help you prepare the clinical and economic evidence for assessment and plan engagement with SHA and the panel secretariat.
Explore reimbursementWe bring together clinical effectiveness, safety and value evidence around an appropriate local comparator, in a form assessors can review.
We model cost-effectiveness with Kenyan cost and disease data, then examine what funding the intervention could cost the relevant fund.
We help you prepare for discussions with the Ministry of Health, the Social Health Authority and the panel secretariat, including what evidence needs to be ready and when.
We help you manage the changes, renewals and obligations that continue after approval.
We keep track of variations, renewals, pharmacovigilance obligations and agreed commitments after approval.
We bring together the evidence and submissions needed to apply for a wider indication.