SFDA's manufacturing licence, issued following satisfactory GMP inspection. Required before any pharmaceutical product can be manufactured in Saudi Arabia for domestic sale or export.

UAE MOHAP and SFDA both reference WHO GMP as the baseline. For EU-origin products, EU GMP certificates are accepted. We advise on the applicable standard for your specific situation.

ALCOA+ principles ensuring pharmaceutical records accurately reflect manufacturing and testing — Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available. SFDA, DHA, and MOHAP have all issued data integrity findings.

DHCA is UAE's primary healthcare cluster, regulated by DHCA and DHA. Pharmaceutical manufacturers within DHCC face both DHCA facility requirements and DHA product licensing requirements.

Initial licence application, periodic surveillance, post-market complaints or adverse events, import certificate applications, and responses to reports from foreign regulatory authorities.

Data integrity deficiencies, inadequate CAPA systems, cleaning validation gaps, OOS investigation failures, environmental monitoring deficiencies, and supplier qualification weaknesses.

Demonstrating that a storage facility maintains required temperature conditions throughout its volume under UAE/Saudi conditions — including summer extremes. Critical for pharmaceutical GDP compliance.

Yes. For UAE MOHAP and SFDA product registrations, pharmacovigilance system establishment is a registration requirement. Nathan supports PV system design as part of comprehensive pharmaceutical quality support.

Yes. We conduct mock inspections using regulatory inspection protocols — not management system audit checklists. Our mock inspections are conducted by consultants who understand how MOHAP, DHA, and SFDA inspectors approach pharmaceutical facility assessments.