+251 913602232
24/7 Support
+251 963283710
24/7 Support
info@saffronpharmaceutical.com
Gerji, imperial behind noc gas station
24/7 Support
24/7 Support
Gerji, imperial behind noc gas station
For regulatory and dossier inquiries:
Saffron General Trading PLC provides professional regulatory affairs services to support compliant pharmaceutical product registration and sustained market presence in Ethiopia.
Our regulatory team works closely with the Ethiopian Food and Drug Authority (EFDA) to coordinate dossier preparation, submission, follow-up, and lifecycle compliance management. We assist international manufacturers in navigating local regulatory frameworks efficiently and responsibly.
We prioritize accuracy, completeness, and proactive communication to facilitate smooth market entry.
Entering a regulated pharmaceutical market requires structured planning and regulatory precision. Our team supports manufacturers by identifying documentation gaps early, ensuring translation accuracy where required, and coordinating submission processes professionally.
We support registration of pharmaceutical products and selected healthcare commodities in accordance with EFDA guidelines and national regulatory scope.
Yes. We provide structured local regulatory representation and coordination support.
By conducting pre-submission technical reviews, ensuring CTD accuracy, and proactively addressing documentation gaps before formal filing.
Yes. We support renewals, variations, and ongoing compliance tracking to maintain product authorization.
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