We simplify your journey with the SFDA by handling every step of the regulatory process. From assessing product eligibility and organizing eCTD dossiers to handling submissions, variations, and renewals, we ensure full compliance and smooth approvals.

Our team proactively monitors regulatory updates, provides strategic insights, and communicates directly with the SFDA on your behalf.

Whether you need guidance on classification, labeling, or post-marketing requirements, we deliver end-to-end support that keeps your products compliant, competitive, and market-ready.

MRG will be your trusted legal representative and license holder, taking full responsibility for regulatory compliance and product management in Egypr. We handle end-to-end registration for human pharmaceuticals, prepare and validate technical documents, and compile CTD/eCTD dossiers for both local and export submissions.

Our team manages labeling, artwork, and all types of regulatory variations, while also overseeing critical files such as stability, analysis, and bioequivalence studies with continuous follow-up until approval.

As an EDA-registered pharmacovigilance provider, we deliver complete PV services from PSMF and RMP to ICSRs and PBRER ensuring patient safety and compliance. We also support compliant product advertising and provide expert consultations to guide your pharmaceutical strategy every step of the way.

We provide end-to-end regulatory support in the UAE, ensuring seamless compliance and market entry for pharmaceuticals and medical products. Our services cover the full approval process, from navigating regulatory pathways and managing CMC documentation to publishing dossiers and handling submissions with accuracy and efficiency.

We also simplify data management through secure client system entry, offer confidential outsourcing solutions to manage your regulatory profile, and deliver expert consultations tailored to the UAE's distinctive regulatory landscape.

With our guidance, your products achieve compliance, approval, and a smooth launch into the market.