Regulatory Services in Saudi Arabia

Regulatory Affairs Services Provider in Saudi Arabia

Earlier, the Ministry of Health(MoH), Saudi Arabia, served as the sole regulatory body responsible for the registration, regulation, and approval of all medicinal and health products including monitoring their safety, efficacy, and quality.In 2003, the Saudi Food and Drug Authority(SFDA) was established as an independent institution reporting directly to the Council of Ministers.Since then, the SFDA has become renowned for having the most stringent regulations and requirements for medicinal product market authorization in the Middle Eastern region.

Generic products must undergo validation, assessment, pricing evaluation, testing, and inspection, and must present product licensing and GMP certification before being granted market authorization ensuring rigorous pharmaceutical regulatory affairs in Saudi Arabia. These strict SFDA regulatory affairs services and measures are in place to ultimately ensure patient safety. Though the SFDA has implemented a strong regulatory service framework, manufacturers often face obstacles when obtaining market authorization due to continually evolving and stringent regulations.

Why partner with DDReg for Regulatory Affairs Consulting in Saudi Arabia ?

DDReg offers best -in -class SFDA Regulatory Affairs Services and Saudi Arabia Regulatory Consulting.We provide ongoing support and development of customized regulatory services in Saudi Arabia strategies across all regulatory phases.Our team continuously monitors the latest regulatory requirements to ensure high - quality, timely submissions.We deliver robust safety measures, ensure effective risk mitigation, and collaborate with experts to facilitate seamless product launches, regulatory filings, and market authorizations.