Expert guidance on ethics and regulatory submissions, import permits, and ongoing regulatory compliance throughout the study lifecycle.
Ethics & Regulatory Submission
Endago provides comprehensive support for ethics and regulatory submissions required to conduct clinical research in Tanzania and across East Africa. Our team ensures every submission is prepared accurately, submitted on time, and followed up until approval is granted.
What We Handle
- Ethics Committee Submissions — Full preparation and submission of ethics applications to national and institutional review committees.
- Regulatory Notifications & Authorisations — Managing all regulatory notifications, clinical trial authorisations, and import permits required for study conduct.
- Amendments & Protocol Modifications — Preparing and tracking submissions for protocol amendments, informed consent updates, and safety reports.
- Ongoing Compliance Monitoring — Annual renewals, progress reports, serious adverse event notifications, and end-of-study submissions.
- Regulatory Strategy & Guidance — Advising sponsors on the regulatory pathway, timelines, and documentation requirements for studies in the region.
Key Regulatory Bodies
We work with and submit to the following national authorities and bodies in Tanzania and East Africa:
- TMDA — Tanzania Medicines and Medical Devices Authority
- NIMR — National Institute for Medical Research (Ethics)
- COSTECH — Commission for Science and Technology
- MUHAS SERU — Muhimbili University Senate Ethics Review Committee
Why It Matters
Regulatory approval is the critical first gate for any clinical study. Delays in submissions or incomplete dossiers can derail timelines significantly. Endago brings deep local knowledge and established relationships with regulatory bodies to keep your study moving forward.