Supporting access to the Saudi market since 2014.
Regulatory Affairs Consulting
We provide regulatory consultation and direct services to secure products approvals with end to end support from manufacturing, through registration, to post-marketing surveillance.
Products and manufacturers registration in SFDA and central GCC/GHC approvals.
Postmarketing surveillance services including building PV systems PSMF/PSSF and QPPV outsourcing.
Empower your decisions by utilizing our insightful opinion, market research, and intelligence reports. We guide, plan, and implement projects related to product launch into the Saudi market.
Choosing the right regulatory partner is crucial for businesses since it has a direct effect on commercial stability. We execute your projects with a full sense of the commercial need for a seamless flow of supply to the Saudi market.
What we support
Herbal & Health
“For us, there is nothing more satisfying than achieving regulatory milestones, specifically marketing approvals. A feeling that repeats itself whenever we physically encounter a product we licensed in the market.
We’re looking forward to working with you in creating a success story and experience our service grade, knowledge level, and creative regulatory solutions.”
Founder, Principal Consultant
Learn about the requirements and timelines of the SFDA verification and abridged registration procedure.
Learn how to apply for SFDA priority review, what are the requirements and condition and how short is the reduced timelines?
Learn how to develop a regulatory strategy for your product registration in Saudi Arabia SFDA. What is the basic structure and the benefits.
Updated SFDA drug registration requirements and approval process description in Saudi Arabia. Guidelines, eCTD dossier, application, and fees.
Our Core Services
Drug and product registrations are our core services. We excel with our unique details oriented planning to guarantee expected outcomes on time.
Experienced xSFDA and xR&D professionals ready to plan and execute your regulatory projects in Saudi Arabia and GCC countries.
7164 Othman bn Affan Rd
Office No 13
Riyadh, 13317. Saudi Arabia
Contact us now to take a step toward unlocking the Saudi Arabia market. You can discuss your needs and challenges to receive complimentary advice and clarity on ways of working.
discuss your project
Book your suitable time to receive a call to explore your options and discuss your project.