Supporting access to the Saudi market since 2014.
Your Regulatory Consulting Partner in Saudi Arabia
We provide regulatory consultation and direct services to secure SFDA approvals for drugs and medical devices with end to end support from manufacturing, through registration, to post-marketing surveillance.
We design and implement innovative & visionary regulatory strategies to support your business decisions.
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 decision making 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 impact on their stability. In PharmaKnowl, regulatory projects are implemented with a full sense of your commercial needs for a seamless flow of supply to the Saudi market.
What we support
Herbal & Health
“For us, there is nothing more satisfying than achieving a regulatory milestone, specifically marketing approvals. A feeling that repeats itself whenever we see on a pharmacy shelf one of the products that we had licensed into the market.
We’re looking forward to working with you on creating yet another success story...”
Founder, Principal Consultant
Detailed list about the SFDA approval timelines for drug application evaluation. The time needed to register and launch your drug in the Saudi market.
Learn about authorized representative company licensing in Saudi Arabia, SFDA requirements, fees, and the role of the authorized representative company.
Details about SFDA medical devices registration. The requirements of different medical devices classes, fees, timelines, and other notes.
Requirements for eCosma SFDA system and registration fees. Learn how to register your cosmetics products and manufacturers.
Description of SFDA registration in Saudi Arabia for products and companies covering drug, health, herbal, medical devices, and veterinary products.
A summary of stability studies requirements in SFDA and GCC countries. What are the minimum time, zone, and accepted commitments?