Regulatory affairs · Digital health · Consultancy
We take medicines from dossier to approval.
Pharma Solutions Hub prepares, files and defends medicine registrations with TMDA and across the East African Community — and builds the digital systems that keep them compliant after launch.
Founded by three registered pharmacists and a health-systems engineer. Two of us used to review dossiers on the other side of the desk.
DAY 0–45
DAY 60
DAY 120
DAY 150
DAY 180
A registration we manage end-to-end. Timelines vary by product class — we tell you yours before we start.
Why clients pick us
Former TMDA insiders. We've sat on the reviewer's side of the desk — so your dossier arrives the way a reviewer wants to read it.
Registered pharmacists on the founding team
3 + 1 engineer
Dossier formats we file
CTD & eCTD
Markets reached through one desk
TZ → EAC
Schedule of services
Six service lines, one accountable team. Every engagement is scoped against this schedule — no surprises in the invoice.
FULL SCHEDULE →Regulatory intelligence
What changed at TMDA and across the EAC this month — read it here before it reaches your inbox as a query letter.
ALL INSIGHTS →New eCTD validation criteria: what changes for importers from July
The updated technical validation checklist tightens Module 1 metadata. Here is what fails screening now — and how to fix it before you submit.
READ — 6 MINOne dossier, six regulators: using the EAC joint assessment well
The harmonised procedure can cut months off multi-country registration — if your dossier is structured for it from day one.
READ — 8 MINYour obligations don't end at authorisation. Neither does our work.
Post-marketing surveillance requirements in Tanzania, explained — and the reporting calendar every marketing authorisation holder should keep.
READ — 5 MIN