top of page
REGULATORY CLARITY. REGISTRATION SUPPORT. COMPLIANCE NAVIGATION
Manufacturer Representation.
Scientific Office Setup.
ITD Egypt supports foreign medical-device and IVD manufacturers with an official local regulatory presence through the Authorised Scientific Office framework, subject to EDA and product-specific requirements.
We provide local representation, document management, regulatory coordination and EDA follow-through under a clearly defined product-specific mandate.
Browse scientific office setup ↓
THE SUPPORT WE PROVIDE
A Clear Scope.
Local Follow-Through.
01
Scientific Office Representation
Local regulatory representation for foreign manufacturers before EDA for medical devices and IVDs, within the applicable licensing framework.
02
Documentation & Submissions
Prepare, organise and coordinate regulatory documentation, dossiers, document-readiness checks and submission inputs.
03
Communication & Follow-Up
Coordinate meetings and EDA correspondence, track open queries and actions, and maintain local follow-up.
04
Lifecycle Tracking
Support registration milestones, renewals, post-registration activity and ongoing compliance coordination.
SCIENTIFIC OFFICE / EDA LIAISON
A Local Regulatory Presence.
A Clearly Defined Structure.
Scientific Office representation is subject to applicable EDA licensing and product-specific requirements. The office, personnel and manufacturer documentation must be confirmed for the agreed structure.
WHAT ITD EGYPT CAN MANAGE
End-to-End Support.
Managed Locally.
The scope can cover representation and registration through renewals, import coordination and post-market support, tailored to the product, manufacturer and regulatory pathway.
THE TEAM BEHIND THE SERVICE
Specialised People.
A Connected Service.
Regulatory Affairs Specialist Team
Regulatory assessment, dossier review, classification support and technical readiness review.
Regulatory Coordinator Team
Submission management, follow-up, document coordination and client communication.
Legal & Compliance Support
Regulatory agreements, authorization templates, compliance review and contractual support.
Document Management
Regulatory record retention, file organisation and controlled document tracking.
Vigilance Support
Basic post-market vigilance coordination and escalation routing.
Administration Team
Management, administration, local support infrastructure and commercial service coordination.
END-TO-END TEAM OPERATIONS
Define the Work.
Make Progress Visible.
Deliverables are tailored to the agreed engagement. They may include:
A project scope and responsibility map
A document-readiness and action tracker
A correspondence and query record
An agreed milestone and lifecycle register
HOW WE WORK TOGETHER
01
Clarify Products and Responsibilities
Define the product scope, intended activity and responsible parties, including any licensed delivery partners.
02
Coordinate Document Readiness
Organise and review documentation from manufacturers, partners, importers or distributors.
03
Track Correspondence and Open Actions
Manage meetings, EDA queries, correspondence, actions and follow-up.
04
Maintain Agreed Milestone Visibility
Track registration, renewal
and other agreed regulatory milestones and timelines.
YOUR QUESTIONS
Before We Begin.
bottom of page