Comprehensive support in navigating Saudi regulatory requirements, focusing on strategy development, submissions, and efficient life cycle management.
Regulatory Projects & Operations
Saudi QPPV & Pharmacovigilance services ensure compliance with Saudi safety regulations through continuous monitoring, reporting, and adherence to local guidelines.
Third Party Service Provider
SFDA Consulting
Expert guidance on regulatory compliance, registration pathways, pricing, manufacturing, distributors, and approval, ensuring smooth market access in Saudi Arabia.
Regulatory and Business Strategy
Market Entry
We simplify Saudi market entry for Pharmaceutical, BioTech, and MedTech companies by guiding and clarifying different entry routes, planning, and executing.
Entry Routes and Conditions
Our quality services encompass QMS development, investigations, validation, GxP compliance, GMP audits, and ISO certification for robust regulatory alignment.
PIC/S and ISO Compliance
Representation
Operating as a non-commercial agent & authorised representative to support our partners’ activities and interact with the authorities on behalf of international companies.
Independent and Direct Communication
Have Questions? Lets Connect..
Contact us to schedule a call, request details, or get a tailored proposal.