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

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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.

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

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Regulatory Insights

Your Trusted Regulatory Intel Source

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Most Recent

SFDA recall procedure in Saudi Arabia

Product Recall in Saudi Arabia

SDEA-Requirements-by-SFDA

SDEA Agreement Requirements by SFDA

The registration timelines in SFDA for all types of products.

SFDA Timelines

What are the reference countries in SFDA?

SFDA Reference Countries

How to submit a safety report ICSR to SFDA

Submission of Individual Case Safety Reports (ICSRs) to SFDA

How to submit a PSUR to SFDA and what are the requirments?

Periodic Safety Update Report (PSUR) Submission 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.