Saudi market entry rarely fits into a single lane. Registration, clinical research, pharmacovigilance, and expedited access are usually decided together. Sponsors with rare-disease assets, small portfolios, or products still in late-stage development need a partner who can move on all of them at once.

Background

Pharma Knowledge (PharmaKnowl) was established in 2014 in Riyadh, Saudi Arabia, as a regulatory consulting firm and has evolved into a functional service provider FSP in regulatory, pharmacovigilance, and clinical research.

PharmaKnowl is a licensed contract research organization (CRO) recognized by the Saudi Food and Drug Authority (SFDA), providing direct services to international sponsors and serving as a subcontractor for global CROs.

With a team fully based in our Riyadh office, we combine on-the-ground knowledge with global understanding.

We Understand..

We understand what is at stake when you are bringing a product to a market you do not operate in every day, especially when timelines are compressed and stakes are high. Since 2014, we have helped global pharmaceutical and biotechnology companies enter Saudi Arabia with regulatory strategies and clinical research programs aligned to authorities’ expectations, delivered by a fully local, Riyadh-based expert team.

Regulatory Depth Meets CRO Capability

PharmaKnowl operates as both a regulatory affairs firm and a CRO licensed by the SFDA. That means clinical research and regulatory work happen inside the same team, with the same accountability, on the same timeline.

For sponsors with rare-disease assets, orphan indications, or small portfolios, this matters. These programs rarely have the resources to manage two separate vendors, and they often need regulatory and clinical strategy to inform each other in real time. A trial design decision affects a submission. A submission decision affects the trial. Handoffs between separate teams cost time.

We work on expedited SFDA pathways, including Orphan Drug Designation, Priority Review, and Compassionate Use, and we can position these pathways while a product is still in Phase 3 development. In practice, this means Saudi patients can access treatments earlier, and sponsors gain regulatory footing well before a conventional launch timeline would allow.

How We Work With You

Step 1: Assess
We review your product, target authorities, clinical status, and business timeline to understand exactly where you are and where you need to be.

Step 2: Strategize
We design the pathway. Which SFDA route, what expedited options apply, whether clinical evidence from ongoing trials can support early access, what submission strategy will minimize timeline risk.

Step 3: Execute
We handle SFDA submissions, correspondence, clinical trial operations, pharmacovigilance obligations, and lifecycle management as your local team. You get one partner, one accountable point of contact, and a plan that moves.

Principal Consultant, CEO

Former Chief Regulatory Pharmacist at the Saudi Food and Drug Authority (SFDA). Bringing over 20 years of experience across the Pharmaceutical, Biotech, and MedTech industries in Saudi Arabia

Mohammed Jobran

Our Team

Behind PharmaKnowl is a dedicated team of regulatory, clinical, quality, and pharmacovigilance professionals with deep expertise in the Saudi life sciences landscape. Our consultants include former SFDA officials, licensed pharmacists, and medical technologists, all working on-site at our Riyadh office to ensure consistent, high-quality service.