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.
Our Expertise
Regulatory Strategy
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 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.
Commercialization
Why PharmaKnowl?
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.
SFDA Experience
Having previous SFDA work experience enables us to provide acumen advice in alliance with the authority expectations.
High Knowledge
Always updated with the latest regulations since knowledge is our asset and business product that we provide to our clients.
Clients Profile
Trusted by clients from global top 10 pharmaceutical and biotech companies.
Qualified Staff
Our staff are equipped with extraordinary experience and training records.
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 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.”
Mohammed Jobran,
Founder, Principal Consultant
Our Blog
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?
SFDA GMP: Manufacturer Registration Process
Manufacturers have to comply with SFDA GMP requirements to be allowed to market in Saudi Arabia. Learn about that in this article.
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.
Our Team
Experienced xSFDA and xR&D professionals ready to plan and execute your regulatory projects in Saudi Arabia and GCC countries.
discuss your project
Book your suitable time to receive a call to explore your options and discuss your project.