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

Since commercial and marketing modules vary in the Saudi market with a direct impact on profit margins, we support the new access for international companies with insights and SWOT analysis on all available trade pathways.

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

beauty, cosmetic, products

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

Mohammed Jobran,

Founder, Principal Consultant

Contact Us

  • Please check applicable fields to your company

Our Blog

sfda medical devices class registration and regulations
Regulatory Affairs
PharmaKnowl

SFDA Medical Devises Registration

Details about SFDA medical devices registration. The requirements of different medical devices classes, fees, timelines, and other notes.

SFDA products registration Saudi Arabia
Regulatory Affairs
PharmaKnowl

SFDA Products Registration

Description of SFDA registration in Saudi Arabia for products and companies covering drug, health, herbal, medical devices, and veterinary products.

Regulatory Affairs
PharmaKnowl

SFDA Stability Study Requirements

A summary of stability studies requirements in SFDA and GCC countries. What are the minimum time, zone, and accepted commitments?