Services
Registrations that get through first time
Strategy, dossiers and lifecycle management with each East African regulator, from first submission to renewal.
What’s included
Product registration
Registration of medicines, medical devices and health products with the Pharmacy and Poisons Board and other East African regulators, including EAC joint assessment where it applies.
Registration dossiers
Dossiers in the Common Technical Document (CTD) format, checked against current guidance before submission.
Variations and renewals
Changes and renewals filed on time so your registration never lapses.
Local technical representative
A Kenya-based representative for manufacturers outside Kenya, as the Pharmacy and Poisons Board requires.
What you receive
- A registration plan per market
- A checked CTD dossier
- Query responses handled for you
- A lifecycle calendar for variations and renewals
How it runs
Regulatory Affairs FAQ
Yes. We plan one dossier that is adapted for each regulator.
Yes, where the regulator requires a local representative for a foreign manufacturer.