Alshedwy Group

medical devices

About

Alshedwy Group is a Saudi Arabian commercial and industrial company founded in 1999, employing around 95 people. The company specializes in regulatory affairs and consulting services for medical device and in vitro diagnostic manufacturers looking to enter and comply with regulations in Saudi Arabia and Egypt. With dedicated regulatory arms in both countries, Alshedwy Group acts as the Saudi Authorized Representative for manufacturers without a local presence, managing the registration process with the Saudi Food and Drug Authority and coordinating adverse event reporting. The company also assists with compliance for marketing materials and maintains ongoing communication between manufacturers and regulatory authorities. Headquartered in Mecca, Saudi Arabia, Alshedwy Group leverages local expertise and strong connections with global regulatory consultancies to support its clients in navigating the regulatory landscapes of two rapidly growing medical device markets. Its customer base includes both overseas and local manufacturers seeking regulatory representation and licensing services.

Technologies

Gmail Google Apps Apache WordPress.org Mobile Friendly Google Analytics

Keywords

saudi mdivd authorized representative saudi mdivd regulatory affairs consultancy saudi biopharmaceutical regulatory affairs consultance saudi mdivd compliance process medical device compliance saudi arabia medical device registration saudi authorized representative regulatory consulting firm medical device regulation egypt regulatory support team device approval egypt regulatory submission regulatory submission management regulatory approval saudi arabia local representation regulatory approval egypt device approval saudi arabia market access egypt regulatory compliance services regulatory strategy egypt device registration process healthcare legal services device classification egypt services regulatory affairs advisory medical device registration process egypt regulatory updates egypt regulatory consulting services regulatory liaison

Location

Jeddah, Makkah Province, Saudi Arabia, 22426

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