Regulatory affairs · Digital health · Consultancy
Your partners in regulatory, compliance, digital and market access solutions.
Pharma Solutions Hub provides expert support for the preparation, submission, and navigation of complex regulatory requirements, while delivering digital solutions that keep health products market-ready and compliant across Tanzania, East Africa, and beyond.
Registered pharmacists and a health-systems engineering desk, working from the same file. Submissions built the way a reviewer expects to read them.
A registration we manage end-to-end. Timelines vary by product class; we tell you yours before we start.
Why clients pick us
We file to today's standard, not last cycle's.
- Dossiers gap-checked against applicable regulatory requirements (TMDA, WHO, EMA, ICH, FDA)
- Submission-readiness checklists provided
- Detailed technical recommendations and corrective actions
- Market knowledge and in-depth analysis
- Regulatory pharmacists and an engineering desk on one file
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 →One 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 MINGMP inspection findings we keep seeing — and how to close them early
Five recurring observations from recent site inspections, with the remediation evidence inspectors actually accept.
READ · 7 MIN