Regulatory Affairs Services 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.
Our Regulatory Consulting Services In Saudi Arabia Portfolio Covers
- SFDA Regulatory Affairs Consulting
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- Regulatory Labeling
- eCTD Regulatory publishing and Submission
Our Regulatory Affairs Consulting Services in Saudi Arabia portfolio covers:
01
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
02
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
03
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
04
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
05
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
06
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
07
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
08
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
09
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
10
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
