eCTD Outsourcing — From Dossier to Submission.
EMCO Egypt compiles and submits eCTD dossiers for SFDA (Saudi Arabia), EMA (Europe), EDA (Egypt), and GCC authorities using eCTD Radar — our EMA R2 and R3 validated dossier software.
eCTD is now required. We have held EMA validation since before Egypt made it mandatory.
The electronic Common Technical Document is the submission standard for Gulf countries, the EMA, and an expanding range of EDA submissions. EMCO Egypt has been building and submitting eCTD dossiers since the format was adopted in our markets.
1. Dossier Compilation & Technical Validation
We prepare the complete eCTD dossier — Module 1 through Module 5 — using eCTD Radar, our EMA R2 and R3 validated software. XML backbone generation, PDF bookmarking, hyperlink validation, and pre-submission technical checks are all part of every dossier we compile.
For Gulf submissions, we adapt Module 1 (regional administrative documents) for each target authority: SFDA, MOH/DHA, GCC. For EMA submissions, the output meets the R3 specification confirmed through EMA validation.
2. Lifecycle & Sequence Management
eCTD submissions are not one-time events. Variations, renewals, and responses to agency queries must be correctly positioned in the submission lifecycle. EMCO Egypt plans and manages the full sequence history for each product — ensuring every new submission is correctly linked to the product's existing lifecycle context.
Reg Radar tracks renewal dates, variation deadlines, and outstanding agency queries for every product in the portfolio — so nothing lapses.
Markets we submit to
Egypt (EDA)
eCTD format submissions for EDA where required. Full CTD dossier preparation including Arabic Module 1 labelling and local agent documentation.
Saudi Arabia (SFDA)
eCTD v3.2 and v4 dossiers for SFDA submission. Regional Module 1 adapted for Saudi administrative requirements. Portal submission management.
UAE / GCC
MOH/DHA submissions for UAE and GCC Mutual Recognition Procedure dossiers covering multiple Gulf markets in a single application.
Europe (EMA)
EMA submissions via eSubmission Gateway. eCTD Radar's EMA R3 validation confirms technical conformance with the EMA's current specification.
Tell us which markets you need to submit to.
A 30-minute conversation with EMCO Egypt's registration team maps the eCTD pathway for your product portfolio and target authorities.
Request an eCTD Assessment See eCTD Radar