EGYPT 🇪🇬 - Food & Drug Regulatory Affairs Consultants

OUR SERVICES IN EGYPT 🇪🇬

Regulatory Services in Egypt

Regulatory services are the essential framework for ensuring compliance with standards and laws.

They aim to establish a safe and fair operating environment by monitoring and supervising professional and commercial activities.

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.

Full Scientific Office Setup in Egypt

We support you from start to finish in establishing your scientific office in Egypt — legal formation and presence, licensing, staff requirements, and alignment with EDA regulations.

Medical device and in-vitro diagnostic Registration services

Complete registration management with the Egyptian Drug Authority. We handle the entire submission process, from preparation documents to final approval.

EDA Medical Device Variation Services

We provide streamlined solutions to manage and update your registered medical devices. Our goal is to ensure your licenses remain compliant with regulatory changes without disrupting your operations.

Import Permit Processing

We manage the entire import permit process through the EDA platform—application, follow-up, and issuance—ensuring your products can be legally imported and cleared through Egyptian customs.

Customs Clearance & Medical Release Procedures

We provide full customs clearance and medical release services. Our team manages all documentation, coordinates with Egyptian Customs and the EDA, and ensures your shipments are cleared quickly — minimizing delays, storage fees, and operational risks.

Conformity Certificate Acquisition

We manage the full process of obtaining Conformity Certificates from the Central Laboratories. This includes sample submission, testing coordination, communication with the labs, managing all required analytical tests, and retrieving the final conformity certificate.

Certified Warehousing & Authorized Maintenance Services

We provide certified warehousing solutions for both sterile and non-sterile medical products, along with access to authorized maintenance centers. Our facilities fully comply with Egyptian Drug Authority (EDA) requirements, ensuring proper storage conditions, full traceability, and validated maintenance procedures for regulated medical devices.