Egypt Drug Registration & GCC eCTD Solutions
Expert regulatory services for pharmaceutical market access in Egypt, GCC, and Africa.
Why Companies Trust Us
Regulatory Expertise & Data Integrity
We ensure accurate, compliant, and well-structured regulatory submissions aligned with Egyptian and international requirements.
Efficient Approvals & Submission Strategy
Strategic regulatory planning and submission management designed to support efficient review and approval timelines.
Egypt & Arab Market Knowledge
Deep understanding of Egyptian and Arab regulatory frameworks, supported by experience aligned with global guidelines.
Quality Systems & Continuous Support
Quality management systems, GSDP readiness, and continuous regulatory support throughout the entire product lifecycle.
Our Services
Empowering Global Pharmaceutical Success
We Build Futures
Byet ElKhebra ElDwaea is a specialized pharmaceutical regulatory affairs office providing integrated regulatory solutions to healthcare companies. Our mission i...
Byet ElKhebra ElDwaea is a specialized pharmaceutical regulatory affairs office providing integrated regulatory solutions to healthcare companies. Our mission is to support drug and medical product registration, CTD and eCTD dossier preparation, export market access, and quality compliance in full alignment with regulatory authorities across Egypt, GCC, and African markets.
Our vision is to become the most trusted pharmaceutical regulatory partner in the region by enabling compliant, efficient, and sustainable market access for healthcare companies, and by building a regulatory ecosystem driven by expertise, transparency, and quality across Egypt, GCC, and Africa.
Frequently
Asked Questions
Find clarity on our most frequent inquiries regarding regulatory procedures.
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Consult a Specialist→Request a Regulatory Consultation
Get in touch with our regulatory experts to discuss product registration, regulatory submissions, quality systems, pharmacovigilance, or training support in Egypt and across the Arab region.