REGULATORY AFFAIRS · DAR ES SALAAM
Practical TMDA and TBS guidance for medicines, medical devices, diagnostics, and supplements in Tanzania.
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Clear, practical support at every stage—so you can focus on your product while we help navigate the requirements.
Regulatory expertise in action
Product quality, complete documentation, and the right regulatory pathway all work together.
Choose your regulator. We’ll guide you through the requirements, paperwork, and follow-up.
Comprehensive consultancy for individuals, companies, and institutions working with the Tanzania Medicines and Medical Devices Authority. From product registration to capacity building, we help you stay aligned with TMDA requirements.
Move through the full TBS registration journey, from product classification and document review to certification, with practical support after registration.
We learn about your product and find the right route.
We check formulations, labels and technical documents.
We build the dossier and submit it.
We answer authority queries and amendments.
We stay until approval, and after, including renewals.
From technical decisions to submissions and follow-up, we help you navigate key regulatory requirements.
Review dossier documents for completeness and consistency, prepare the submission, and support follow-up with the relevant authority.
Help determine the applicable device classification and guide the registration documentation and submission process.
Support product and label review, dossier preparation, submission, and follow-up through the registration process.
Assist with finding and coordinating a suitable local technical representative for your regulatory needs.
Help prepare import permit applications, monitor progress, and follow up on requests during the review process.
From TMDA to TBS — we guide you every step of the way.
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