Navigating the pharmaceutical regulatory landscape in Yemen requires deep expertise and precision. Our Regulatory Affairs team ensures that all products comply with applicable healthcare regulations and standards, supporting successful registration, importation, and continuous availability in the market.
Comprehensive management of product registration processes and documentation with local authorities.
Expert preparation and submission of regulatory files (CTD, Dossiers) ensuring compliance.
Assistance with importation licenses and maintaining valid operational permits.
Ongoing monitoring of regulatory changes and ensuring product lifecycle compliance.
Review of product labeling and packaging to ensure they meet local requirements.
Handling product variations and renewals efficiently to avoid market disruption.
A structured pathway to bring your products to the Yemeni market.
Gathering all necessary documents, including CTD, COA, and GMP certificates from the manufacturer.
Preparing and submitting the regulatory dossier to the Supreme Board of Drugs and Medical Appliances (SBDMA).
Continuous follow-up with the regulatory bodies to address any inquiries and facilitate the evaluation process.
Obtaining the final registration certificate, allowing legal importation and distribution in Yemen.
Our commitment extends beyond registration. We ensure product quality and patient safety through continuous monitoring, quality review, and responsible reporting of any adverse events.
Let our experts handle the complexities of pharmaceutical registration in Yemen. Contact us today.
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