Regulatory Services in Saudi Arabia
Saudi Arabia
Earlier the Ministry of Health (MoH), Saudi Arabia, was the regulatory body that was responsible for the registration, regulation, and approval of all medicinal and health products and monitoring their safety, efficacy, and quality. In 2003, the Saudi Food and Drug Authority (SFDA) was created as an independent institution that directly reports to the Council of Ministers. The SFDA is renowned for having the most stringent regulations and requirements for medicinal product market authorization in the Middle Eastern region.. Generic products will undergo validation, assessment, pricing, testing, and inspection processes and must present product licensing and GMP certification before they can be granted market authorization. The strict regulations are put in place to ultimately ensure patient safety. Though the SFDA implements a strong regulatory framework, manufactures face obstacles when obtaining market authorization due to ever-changing and stringent regulations.
As a leading global contender, DDReg’s regulatory services in Saudi Arabia provides on-going support and development of the customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.
DDReg Services include:
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- ICSR Processing and Submission
- Risk Management
- Aggregate Reports
- Signal Management
- QPPV Services
- Bio Waiver Justifications
- Clinical & Non-Clinical Experts Reports
- IPR Support, including Worldwide Patent Status and Patent Reviews