We provide end-to-end regulatory support for product registration and lifecycle maintenance across MENA markets. Our services cover the full spectrum—from product classification and dossier preparation (CTD/eCTD) to pre-submission meetings, authority engagement, and regulatory filings. We ensure that technical files and administrative components are fully compliant with regional authority requirements, including SFDA, EDA, and other MENA agencies.

Post-approval, we manage variations, renewals, and dossier updates to maintain uninterrupted market access. Our regulatory expertise reduces time-to-license, mitigates risk of rejection, and ensures long-term compliance across the product lifecycle.