مكتب استشارات دوائية لخدمات الشؤون التنظيمية والتيقظ الدوائي لتسجيل المنتجات والإمتثال بأنظمة الهيئة العامة للغذاء والدواء في المملكة العربية السعودية

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, enabling successful studies in Saudi Arabia.

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

Expert guidance on regulatory compliance, registration pathways, pricing, manufacturing, distributors, and approval, ensuring smooth market access in Saudi Arabia.

Operating as a non-commercial agent & authorised representative to support our partners’ activities and interact with the authorities on behalf of international companies.