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.
Our Expertise
Regulatory Strategy
We design and implement innovative & visionary regulatory strategies to support your business decisions.
Registration
Products and manufacturers registration in SFDA and central GCC/GHC approvals.
Pharmacovigilance
Postmarketing surveillance services including building PV systems PSMF/PSSF and QPPV outsourcing.
Consultation
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.
Commercialization
Why PharmaKnowl?
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.
Thorough Knowledge
Always updated with the latest regulations since knowledge is our asset and business product that we provide to our clients.
Qualified Staff
Our staff are equipped with extraordinary experience and training records.
SFDA Experience
Having previous SFDA work experience enables us to provide acumen advice in alliance with the authority expectations.
Clients Profile
Trusted by clients from global top 10 pharmaceutical and biotech companies.
Licensed
Inspected by Authorities
QMS
Certified ISO 9001-2015
Backups
Business Continuity Measures
Security
Protected Data Servers
What we support
Pharmaceuticals
Herbal & Health
Medical Devices
Cosmetics
Food Supplements
Veterinary
“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...”
Mohammed Jobran,
Founder, Principal Consultant
Contact Us
Our Blog
SFDA Drug Registration Requirements & Approval Process
Updated SFDA drug registration requirements and approval process description in Saudi Arabia. Guidelines, eCTD dossier, application, and fees.
Development of a Regulatory Strategy for the Saudi Market
Learn how to develop a regulatory strategy for your product registration in Saudi Arabia SFDA. What is the basic structure and the benefits.
SFDA timelines for drug approval, variation, and renewal
Detailed list about the SFDA approval timelines for drug application evaluation. The time needed to register and launch your drug in the Saudi market.
Authorized Representative for Medical Devices: SFDA Requirements Explained
Learn about authorized representative company licensing in Saudi Arabia, SFDA requirements, fees, and the role of the authorized representative company.
SFDA Medical Devises Registration
Details about SFDA medical devices registration. The requirements of different medical devices classes, fees, timelines, and other notes.
eCosma: SFDA Cosmetics Registration Requirements
Requirements for eCosma SFDA system and registration fees. Learn how to register your cosmetics products and manufacturers.
SFDA Products Registration
Description of SFDA registration in Saudi Arabia for products and companies covering drug, health, herbal, medical devices, and veterinary products.
SFDA Stability Study Requirements
A summary of stability studies requirements in SFDA and GCC countries. What are the minimum time, zone, and accepted commitments?
