10+ Years SFDA & GCC Expertise
About Us
Your Trusted Regulatory Partner in Saudi Arabia & GCC
Medwisdom Lifescience Pvt. Ltd., in collaboration with Yamen Al Rawad Medical Company, offers regulatory-to-market pathway, helping partners achieve faster approvals, efficient an integrated regulatory and market access solution for healthcare companies entering and expanding across Saudi Arabia and the GCC region.
Medwisdom Lifescience leads the regulatory strategy, providing compliant and efficient solutions for Pharmaceuticals, Medical Devices, Cosmetics, and Food Products, fully aligned with SFDA and GCC regulatory requirements. Our expertise spans the complete regulatory lifecycle—from product classification and dossier development to digital submissions, licensing, audits, and post-approval compliance.
Yamen Al Rawad Medical Company, based in Riyadh, complements this partnership with strong local distribution and market presence. Established in 2011, the company specializes in the distribution of pharmaceuticals, medical supplies, and laboratory reagents, ensuring reliable logistics and broad coverage across Saudi Arabia. Together, we provide a seamless market entry, and sustainable growth in Saudi Arabia and the GCC.
Our Best Service
What We Offer
Product Registration
Product registration for pharmaceuticals, medical devices, food supplements, and cosmetics
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Company Licensing
Company licensing, importer/agent support, and establishment registration
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Import/Export & Maintenance
Import/Export approvals and ongoing regulatory maintenance services
Read MoreCountries
Our Main Countries
Saudi Arabia
UAE
Qatar
Kuwait
Oman
Bahrain
Saudi Arabia
UAE
Qatar
Kuwait
Oman
Bahrain
Our Core Expertise
Regulatory Affairs
Complete regulatory support from eCTD dossier preparation to product approval across GCC
Pharmacovigilance (PV)
End-to-end PV services including QPPV support, safety reporting, RMP,& PSURs to meet GCC & global safety requirements.
Read MoreMedical Devices
Device classification, MDR, GHTF compliance, MDSAP guidance, and GCC/SFDA device registration with complete regulatory support
Read MoreGeneric Drugs (Pharmaceuticals)
Generic drug registrations with CTD/eCTD dossier preparation, BE study support, stability data review, and GCC-specific documentation.
Read MoreBiologicals & Vaccines
Biosimilars, vaccine dossiers, GMP/GQP, cold-chain & batch release support.
Read MoreClient Feedback
What Our Clients Say
Ready to get start
Talk to us to learn more — our regulatory & PV specialists will guide your product to audit-ready submission and smooth GCC market entry.
Contact UsWhy Choose Us
Trusted Regulatory & PV Specialists
We deliver reliable regulatory and pharmacovigilance support for GCC market entry — on time, confidentially, and with measurable quality.
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Fast & error-free dossier preparation
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Deep knowledge of GCC regulatory pathways
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Strong expertise in PV, RMP, PSUR & post-approval compliance
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100% confidential & client-centric operations
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Dedicated RA & PV specialists
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Transparent pricing & guaranteed timelines
Common Questions
Frequently Asked Questions
What is SFDA approval and how long does it take?
SFDA (Saudi Food and Drug Authority) approval is the regulatory requirement for all pharmaceutical products in Saudi Arabia. The approval timeline typically ranges from 6-18 months depending on dossier completeness, drug classification, and regulatory pathway. MedWisdom specializes in accelerating this process through proactive query management and strategic documentation.
What is pharmacovigilance and why is it mandatory?
Pharmacovigilance is the science and activities related to detection, assessment, understanding, and reporting of adverse effects or any other medicine-related problems. It is mandatory in all GCC countries to ensure public health safety. Manufacturers must maintain a local pharmacovigilance system with a qualified QPPV (Qualified Person for Pharmacovigilance) available 24/7 for adverse event reporting and management.
Which documents do I need for regulatory submission?
A typical regulatory dossier includes: Product information (SPC, labels), Quality data (CMC, shelf-life studies), Nonclinical data (toxicology), Clinical data (safety & efficacy), Pharmacology summaries, Risk management plans, and Environmental assessment. Requirements vary by product type (generic, innovator, biologic, vaccine, medical device). MedWisdom provides guidance on exactly which documents your product requires for your target market.
Is there a difference between GCC and individual country approvals?
Yes. While there is a GCC mutual recognition agreement, individual countries (Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman) maintain separate regulatory requirements and approval processes. However, approval in one GCC country often facilitates approval in others. Our team navigates both individual and harmonized pathways to optimize your market entry strategy across the region.
What is the difference between generic and innovator drug approval?
Innovator drugs require full nonclinical and clinical safety/efficacy data and longer approval timelines (typically 2-3 years). Generic drugs only require bioequivalence studies and comparative quality data, resulting in shorter timelines (6-12 months). Both require local pharmacovigilance systems. MedWisdom has expertise in both pathways and can advise on the most efficient route for your product portfolio.