Resources
These are working documents — the guides, checklists and playbooks behind our own engagements. Read them here, or use them as the basis for a conversation about your portfolio.
Navigating Kenya’s pharmaceutical regulatory landscape: regulatory authorities, product registration pathways and fees, marketing authorization validity, GMP inspections, and the MAH–LTR–importer relationship.
Preparing for regulatory and partner audits in Kenya: core inspection principles, a documentation readiness checklist, facility expectations, team preparation, and the findings raised most often.
Every administrative document, CTD module, and special attachment a PPB submission requires — the quality assurance checklist we run before anything is filed.
Operational and documentation requirements for compliance in Kenya — GSDP requirements for distributors, GMP requirements for manufacturers, supplier qualification, and common non-conformities.
Two obligations that cause more confusion than any others. What each one means, who is responsible, what happens when either is missed, and how to build both into a regulatory calendar.
How a pharmaceutical importer moved from incomplete, generic SOPs to a fully aligned, audit-ready QMS within a defined timeline — and scored highly at prequalification.
In preparation
These are being finalised. Ask us for an advance copy and we will send it when it is ready.
Clearance searches, regulatory naming suitability, and coordinating filings with KIPI — written for regulatory teams rather than IP lawyers.
Periodic summaries of new PPB guidance, changed requirements, and what they mean in practice for products already on the register.
Planning market entry?
A short scoping conversation tells you which PPB pathway applies, what your dossier is missing, and what the realistic timeline looks like.
