Biotech – Pharma – MedTech

Empowering Global Life-Sciences in Saudi Arabia

Regulatory, Clinical, and Pharmacovigilance Consulting Led by Expert SFDA Consultants Supporting Successful Market Entry and Compliance in Saudi Arabia

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Years of SFDA Experience
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Regulatory Projects
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Global Clients

Trusted by Industry Leaders

Fresenius
Abbot Pharma
Chiesi Rare Diseases
Lundbeck
Samsung Biologics
AstraZeneca
Alnylam
Amgen
Panasonic Healthcare
PDI Healthcare
SECA
Quanta System SpA
Snibe Diagnostics
Septodont, France
ZOLL Medical
Essilor

Meet Us at Industry Events

Connecting with Our Partners and Regulators Worldwide

PharmaKnowl at the Global Health Exhibition 2025

Exhibiting at the World Drug Safety Congress, Amesterdam 2025

We are exhibiting in the 24th ISoP Annual Meeting, in Cairo

Expertise – Trust – Excellence

Our Strengths, Your Regulatory Advantage

Combining regulatory expertise, industry versatility, and trusted local presence, we deliver high-impact SFDA regulatory solutions. Our qualified team, cross-sector background, and up-to-date knowledge empower your business to meet compliance requirements with speed and confidence.

Authority-Industry

Backed by SFDA and industry experience, we support strategic planning, regulatory decision-making, and project execution.

Knowledge

Well-versed in evolving regulations and market shifts, delivering sound guidance and actionable regulatory intelligence.

Credentialed

Licensed pharmacists and biotechnologists with hands-on experience across diverse product categories and life science sectors.

Proven

Trusted by leading pharmaceutical, biotech, and MeTech companies as a reliable local partner and authorised representative.

Principal Consultant, CEO

Bringing over 20 years of leadership in regulatory affairs across the pharmaceutical, biotechnology, and MedTech industries.

  • Former Chief Regulatory Pharmacist at the Saudi Food and Drug Authority (SFDA)
  • Former Regulatory & Scientific Office manager for a multinational company.
  • Expert in regulatory strategies, marketing rights, new entry, registration, licensing, manufacturing, pricing, and technology transfers.
  • Holds a BSc in Pharmacy and MSc in Biomedical Informatics
Mohammed Jobran

Mohammed Jobran

Services & Solutions

Explore Our Solutions & Services for Life Science Industries

Regulatory Affairs

Comprehensive support in navigating Saudi regulatory requirements, focusing on strategy development, submissions, local teams, and efficient life cycle management.

Pharmacovigilance

Dedicated department to support your global PV with a third-party local Saudi QPPV to fully comply with local Saudi pharmacovigilance requirements.

Clinical Trials

Comprehensive CRO services covering site selection, contracting, approvals, patient recruitment, trial management, and safety oversight in the Saudi healthcare system.

Quality Compliance

Our quality services encompass QMS development, investigations, validation, GxP compliance, GMP audits, & ISO certification for robust regulatory compliance.

SFDA Consulting

We provide expert guidance on regulatory compliance, registration pathways, pricing, manufacturing, and distributors, ensuring smooth market access in Saudi Arabia.

Saudi Agent

We operate as your non-commercial local agent to enable private and expedited submissions to the authorities, independent of your local distributor.

Resources

Download Expert-Crafted Resources

Down load the authorized representative agreement for SFDA

Template: Authorised Representative Agreement by SFDA

Checklist Medical Device registration MDMA SFDA

Checklist: SFDA Medical Device Required Files (MDMA)

Checklist of Drug Registration requirements by SFDA

Checklist: SFDA Drug Dossier Requirements

Transfer the Authorised Representative AR in SFDA, Saudi Arabia

Case Study: Transfer of the Authorised Representative (AR)

Regulatory Insights

Your Trusted Regulatory Intel Source

Types of products registration in SFDA (Saudi Arabia)

SFDA Registration and Approval Process

SFDA Medical Device Registration (MDMA)

How to register a drug in Saudi Arabia (SFDA)

SFDA Drug Registration Requirements

Learn about pharmacovigilance and QPPV requirements by SFDA in Saudi Arabia

Pharmacovigilance & QPPV Requirements in Saudi Arabia

orphan drug in Saudi Arabia

Orphan Drug Designation (ODD) in SFDA

SFDA expedited pathways & drug designations

Expedited SFDA Pathways and Drug Designations

Most Recent

SFDA incentive list to register shortage drugs

What Is the SFDA Drug Incentive List? Types and Hidden Benefits

SFDA expedited pathways & drug designations

Expedited SFDA Pathways and Drug Designations

How to Register Borderline Products in the SFDA?

eCTD Requirements SFDA

What are the eCTD Requirements in SFDA?

Medical Device Establishment License (MDEL) in SFDA

Medical Device Establishment License (MDEL)

SFDA preclinical study submission process in Saudi Arabia

Preclinical Studies Submissions to SFDA

Company Updates

News & Announcements

Vision – Clarity – Strength

Partnering with You for Regulatory Success

Leverage our expertise in SFDA regulatory consultation services to make informed, confident decisions. We support you in planning, managing, and executing regulatory projects tailored for the Saudi Arabian market.

  • New market entry experts

  • Registration and SFDA Representation

  • Outsourced regulatory solutions provider
  • GMP/ISO Quality Consultation
  • Local Saudi QPPV service

Move Forward With a Partner Trusted by Global Life-Science Leaders

Schedule a call or request a tailored proposal from our team.