Regulatory Services in Egypt

Authorized Representation
& Registration License Holding

We act as your authorized representative in Egypt to register your pharmaceutical or medical device products with the Egyptian Drug Authority (EDA) and build a network of compliant, reliable local distributors.

Comprehensive Regulatory Services
Contact Us

Process Steps

for Authorized Representation & Registration License Holding

Assign us as your Local Authorized Representative

We handle all official communication on your behalf

Build distributor connections

Prepare for registration

FAQs About Authorized Representation & Registration License Holding

Can a foreign company register products in Egypt?

Yes. Foreign manufacturers can register products if they appoint a local authorized representative or establish a licensed scientific office.

Yes, we manage all communication, submissions, follow-ups, and regulatory actions.

Yes, anytime and transfer all you licenses to your own scientific office.

Unlimited — no restriction from EDA.

The Authorized Representative handles regulatory responsibilities, while a distributor handles sales, marketing, and commercial activities.
Maintain full control over all notifications and regulatory submissions.
  • Submit variations, renewals, and updates without needing approval from any distributor.
  • Change the AR or transfer files to another party (including the manufacturer’s scientific office) at any time without restrictions.
  • Avoid being locked into a commercial relationship that limits regulatory decisions.
In short, an AR protects the manufacturer’s regulatory autonomy and ensures maximum flexibility throughout the product’s lifecycle.
Choose FDRAC, Choose the Experience

Why to Choose FDRAC

Experienced team

End-to-End solution

Faster market access

Business-focused approach

Transparent pricing

Proven Experience

Our Experts here for your Company

Ensuring your project’s success

Delivering the highest quality and compliance

Working as an extension of your business

This Service is Right for You

If You Are:

International Manufacturers

Looking to register and access the Egyptian market

Local Agents & Distributors

Managing product registration and compliance with EDA

Healthcare & Medical Businesses

Seeking market entry or expansion in Egypt

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