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Associate Partner

Associate Partner

About Us

We specialize in guiding global pharmaceutical, biotech, vaccine, medical device, and cosmetic companies through the Saudi FDA (SFDA) regulatory landscape—delivering speed, precision, and absolute compliance.

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Who We Are

Medwisdom Lifescience Pvt. Ltd. and Yamen Al Rawad Medical Company together form a strong, strategic collaboration that delivers end-to-end regulatory and healthcare distribution solutions for companies seeking to enter and expand within Saudi Arabia and the GCC region.

Our partnership bridges the gap between regulatory approval and market execution, enabling healthcare manufacturers and brand owners to achieve compliant market access while ensuring reliable product distribution and long-term commercial success.

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Regulatory consulting team Saudi Arabia

Medwisdom Lifescience

Medwisdom Lifescience Pvt. Ltd.

Medwisdom Lifescience Pvt. Ltd. is a trusted regulatory consulting partner specializing in Pharmaceuticals, Medical Devices, Cosmetics, and Food Products. We support clients throughout the complete regulatory lifecycle in Saudi Arabia and GCC countries, ensuring full compliance with SFDA and regional regulatory authority requirements.

Our Core Services

Our services include product classification, technical evaluation, CTD/eCTD dossier development, digital submissions, licensing, audit support, and post-approval regulatory compliance.

Our Approach

With deep regional expertise and a strategy-driven approach, we provide customized regulatory solutions that simplify complex pathways and accelerate time to market.

Yamen Al Rawad

Yamen Al Rawad Medical Company

Yamen Al Rawad Medical Company, established in 2011 and headquartered in Riyadh, Saudi Arabia, is a leading healthcare distribution company. The company specializes in the distribution of pharmaceuticals, medical supplies, and laboratory reagents, supported by a strong infrastructure covering marketing, finance, administration, and logistics.

Nationwide Coverage

With nationwide coverage across the Central, Eastern, Northern, and Southern regions of Saudi Arabia, Yamen Al Rawad Medical Company serves a broad network of pharmacies, hospitals, clinics, and healthcare outlets.

Reliable Supply Chain

The company is recognized for its reliable supply chain, wide market reach, and commitment to consistent product availability and customer satisfaction.

Our Combined Strength

Fully Integrated Regulatory-to-Distribution Model

Together, Medwisdom Lifescience and Yamen Al Rawad Medical Company offer a fully integrated regulatory-to-distribution model, enabling partners to move seamlessly from SFDA approval to commercial launch and sustained market presence.

Efficient Regulatory Approvals

Efficient SFDA and GCC regulatory approvals

Faster Market Entry

Faster and compliant market entry

Reliable Distribution & Logistics

Reliable product distribution and logistics

Strong Market Penetration

Strong market penetration and coverage

Partnership Vision

Building Long-Term Partnerships

We believe in building long-term, transparent, and value-driven partnerships. Our collaborative approach is designed to support manufacturers, marketing authorization holders, and healthcare brands seeking a dependable partner for regulatory compliance and market expansion in the Middle East.

Trusted Partners

Medwisdom Lifescience Pvt. Ltd. and Yamen Al Rawad Medical Company — your trusted partners for regulatory excellence and healthcare distribution in Saudi Arabia and the GCC.

Sustainable Growth

Long-term, sustainable business growth in Saudi Arabia and the GCC

Our Approach

We Convert Regulatory Complexities into Clear Success

From first submission to post-approval lifecycle management — we manage everything with precision and expertise.

Deep Market Understanding

We understand the unique challenges of the Saudi and GCC markets.

Actionable Strategies

We convert regulatory complexities into clear, actionable steps.

Audit-Ready Delivery

We deliver predictable timelines and full compliance assurance.

Our Services

Comprehensive Regulatory Solutions

End-to-end support across all key areas for the Saudi FDA (SFDA) and GCC markets.

Pharmacovigilance

  • Local QPPV (24/7 availability)
  • Turnkey PV System Setup
  • PSMF, RMP, ICSR, Aggregate Reports
  • PV Audits & Inspection Readiness

Generic Drugs

  • eCTD Dossier Compilation
  • BE Study Support
  • Variations, Renewals & Import Permits

Biologicals & Vaccines

  • Biosimilars & Vaccine Dossiers
  • GMP, Cold-Chain Compliance
  • Stability & Batch Release Support

Medical Devices

  • MDMA Registration & Technical Files
  • UDI & Post-Market Surveillance
  • Vigilance & FSCA Support

Cosmetics

  • Product Notification & CPSR
  • PIF Preparation & Labelling
  • Cosmetovigilance

Why Choose Us

Why Partner with Us

Saudi-focused expertise delivering unmatched precision, speed, and long-term compliance success.

Saudi-Focused Expertise

Exclusive specialization in SFDA regulations and GCC harmonization.

Precision & Speed

Proactive strategies to reduce queries and accelerate approvals.

All-in-One Support

Complete lifecycle management under one trusted partner.

Trusted Team

Experienced consultants, reviewers, and compliance specialists.

Proven PV Leadership

Robust systems trusted by international companies with zero critical findings.