Product Registration Services in Egypt
Byet ElKhebra ElDwaea provides comprehensive product registration services in Egypt, supporting pharmaceutical and healthcare companies throughout the full regulatory approval process. Our regulatory affairs experts manage product registration in full compliance with Egyptian Drug Authority (EDA) requirements, ensuring accurate submissions, efficient approvals, and successful market entry.
EDA • Risk-Based • Built for Speed
Request Product Registration SupportWhat Products Do We Register?
We support registration of a wide range of healthcare products in Egypt, following the appropriate regulatory pathways for each category.
Product Categories:
Each product category is handled according to its specific regulatory classification and submission requirements.
Our Product Registration Process
Our structured regulatory process is designed to minimize delays and ensure full compliance.
Step-by-Step Process:
- 1
Regulatory pathway assessment and product classification
- 2
Gap analysis of available documentation
- 3
Dossier preparation and technical review
- 4
Submission to Egyptian Drug Authority (EDA)
- 5
Regulatory follow-up and deficiency response
- 6
Final approval and market authorization support
Why Choose Us for Product Registration in Egypt?
- Deep knowledge of Egyptian regulatory requirements
- Experience across multiple product categories
- Accurate documentation and data integrity
- Continuous communication with regulatory authorities
- Proven success in achieving timely approvals
Regional Market Access Support
In addition to Egypt, we support product registration and market access across the Arab region, including GCC countries, in alignment with local regulatory authorities and regional guidelines.
Frequently Asked Questions
Q: Which authority handles product registration in Egypt?
A: Product registration is managed through the Egyptian Drug Authority (EDA).
Q: Do you support registration for imported products?
A: Yes. We support registration of both locally manufactured and imported products.
Q: Can you support registration outside Egypt?
A: Yes. We provide regulatory support across the Arab region and GCC markets.
Request Product Registration Support
Contact our regulatory experts to discuss your product registration requirements in Egypt and the Arab region.
Request Product Registration Support