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Practical guidance on pharmaceutical regulatory affairs in East Africa — written for RA teams, LTRs, and MAHs who work with the PPB and other authorities.
Kenya's Pharmacy and Poisons Board aligns closely with the ICH CTD structure, but several requirements are specific to local practice. We break down what to expect module by module.
Read moreIn Kenya, the Local Technical Representative and the Marketing Authorisation Holder have different regulatory responsibilities — yet most teams conflate them. Here's what each role actually owns.
Read moreSpecification acceptance criteria that do not match the stability protocol. A batch analysis CoA with different values than the finished product specification. Both documents passed review. Neither triggered an alarm.
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We publish guides on CTD structure, PPB requirements, and practical RA workflow. No noise.