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.
Registered pharmacists and a health-systems engineering desk, working from the same file. Submissions built the way a reviewer expects to read them.
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
We track every TMDA and EAC guideline update closely, so each submission meets the standard reviewers expect today, not the standard last cycle's template left behind.
Registered pharmacists on the team
3 + an engineering desk
Dossier formats we file
CTD & eCTD
Where we work
Tanzania-based & worldwide
Schedule of services
Six service lines, one accountable team. Every engagement is scoped against this schedule, so there are 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