Address
Africourts Building , Buganda Road, Kampala (U)
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Phone
+256774546768
E-mail
info@regulix.co.ug
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Frequently Asked Questions
Get quick answers to common questions about our services, regulatory support, and pharmaceutical consulting. Whether you’re a new client or have ongoing projects, we’re here to provide clarity and support at every step.
Regulix Consultancy specializes in providing technical regulatory guidance to foreign pharmaceutical companies. We assist with the compilation of a compliant NDA dossier for submission to the National Drug Authority (NDA). Our services cover the entire market authorization lifecycle, from initial regulatory strategy and documentation to post-market surveillance (pharmacovigilance), ensuring adherence to Uganda's specific Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements.
In addition to regulatory affairs, we provide professional support for pharmacovigilance, clinical trials, compliance with good distribution practices and logistics services like clearing and forwarding, and medicines importation.
The timeframe can vary depending on the product, the completeness of the dossier, and the current workload of the National Drug Authority. We work to streamline the process to minimize delays and keep you informed at every stage.
While our primary focus is the Ugandan market, our expertise in regional regulations allows us to advise on strategies for expanding into other East African countries.