Biotech – Pharma – MedTech

Strategic SFDA Regulatory Consulting

Regulatory, Clinical, & Pharmacovigilance Consulting Services, led by seasoned SFDA Consultants who design, steer, and deliver regulatory success 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

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

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

Saudi QPPV & Pharmacovigilance services ensure compliance with Saudi safety regulations through continuous monitoring, reporting, and adherence to local guidelines.

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

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

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 a non-commercial local agent for our Biotech & Pharma clients who are new to Saudi Arabia. Also, as an authorized representative for the MedTach companies

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

To meet a consultant, or Request a proposal..

Contact us to schedule a call, request details, or get a tailored proposal.