Regulatory & Ethics Support

Running a trial across Sub-Saharan Africa means navigating multiple regulators, ethics committees, and local legal frameworks.

Every African country has its own regulator, its own ethics committee structure, and its own expectations for dossier format, insurance, and import permits. A misread requirement is an extra 60 days on the critical path.

Running a trial across Sub Saharan Africa means navigating multiple regulators, ethics committees, and local legal frameworks. We serve as your local regulatory partner, helping you meet expectations without unnecessary delays.

8 Active
jurisdictions

1st

First-pass
approval
focus

24/7

Safety
reporting

What we do

From first submission to final close-out, fully covered.

Submissions & approvals

Prepare and submit applications to local regulatory agencies and ethics committees in each country.

Lifecycle support

Support amendments, safety reporting, and periodic submissions in line with sponsor and regulatory requirements.

Country-specific advisory

Advise on country specific documentation, insurance, import export permits, and safety reporting rules, including South Africa’s more developed regulatory environment.

Our regulatory footprint

Eight countries. One coordinated submission strategy.

We maintain active relationships with the regulators and ethics committees that govern your trial in each market — and we coordinate timelines so your global program moves as one.

Nigeria

NAFDAC + NHREC

Ghana

FDA + GHS-ERC

Kenya

PPB + KNH-UoN ERC

Uganda

NDA + UNCST

Tanzania

TMDA + NIMR

Rwanda

Rwanda FDA + RNEC

South Africa

SAHPRA + HRECs

Ethiopia

EFDA + NRERC

Less friction. Less risk. One trusted partner.

Faster approval to FPI

Shorter time from approval to first patient in, because applications are tailored to local expectations and submitted efficiently.

Fewer queries & rejections

Fewer regulatory queries and rejection risks, thanks to our experience with African regulatory agencies.

One partner, every country

A single, experienced partner to manage your regulatory landscape across countries, instead of juggling multiple local consultants.