A dossier ready for review
Before you submit, we check the dossier against the requirements, flag gaps and help your team close them.
Why it matters
Clearer evidence when regulators assess the file.
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Regulatory affairs & health technology assessment
Precision in healthcare. Confidence in regulation.
We help you prepare for Pharmacy and Poisons Board registration and make the case for funded access. Tell us about your product and the question you need to answer.
Will it be paid for?
Regulatory strategy. Evidence for access.Registration is one part of the work. Your product may also need a plan for another market, reimbursement or changes after approval.
A clear plan matters as much as a complete dossier.
Ultra Pharma / The practiceYou should know what we are working on, who is responsible and what needs to happen next. Here is how we organise the work.
Before you submit, we check the dossier against the requirements, flag gaps and help your team close them.
Why it matters
Clearer evidence when regulators assess the file.
When a query, filing or inspection needs urgent attention, we bring together the team to deal with it.
Why it matters
A clear response when timing matters.
Each market has its own requirements. We adapt your dossier and work with local partners to address them.
Why it matters
You know what needs to change for each market.
We put procedures and traceable records in place as the work develops, so your team can use them and prepare for inspection.
Why it matters
Records your team can use and inspectors can follow.
We can agree milestone fees, retainers or outcome-linked terms depending on the scope and risk of the work.
Why it matters
An engagement structure that matches your priorities.
We share the work through practical workshops, SOP handovers and mentoring, so your team can take more of it forward.
Why it matters
Tools and knowledge your team can keep using.
Can it be sold?
We help you prepare for registration in Kenya and keep the supporting quality systems ready for inspection.
Can it reach the market?
We adapt your existing dossier to the next market, keeping local requirements in view.
Will it be paid for?
We help you prepare the evidence authorities need when they assess the case for funded access.
Does it stay valuable?
We help you manage renewals, changes and the work that continues after approval.
Coverage under the Social Health Authority flows through three funds. What that structure changes for a product that already holds Pharmacy and Poisons Board registration.
The Benefits Package and Tariffs Advisory Panel was gazetted in April 2025. What its published mandate covers, and what it does not.
The file you submit and the way you answer queries affect the review. A practical look at what your team can prepare.
Primary healthcare services
Benefits at the tariff set for each service
Cover beyond the insurance benefit
Social Health Insurance Act 2023
Benefits Package and Tariffs Advisory Panel
Kenya replaced NHIF with the Social Health Authority under the Social Health Insurance Act 2023. What SHA pays for, and at what tariff, is shaped by health technology assessment through the Benefits Package and Tariffs Advisory Panel.
A product can be fully registered with the Pharmacy and Poisons Board and still sit outside the benefits package, competing on out-of-pocket price against a funded alternative. Closing that gap is a different discipline from registration.
Explore health product assessmentA short outline of your product and the help you need is enough to start. You can use the form or contact us directly.
Prefer email? Contact us directly with a short outline of your enquiry.