eCTD Radar
eCTD dossier software that has been through EMA validation twice — R2 in 2022, R3 in 2024.
The only Egyptian-built eCTD software with EMA R2 and R3 validation.
eCTD Radar generates XML backbones, manages dossier structure, and produces submission-ready eCTD packages for regulatory authorities in Egypt (EDA), the Gulf (SFDA, MOH/DHA, GCC), and Europe (EMA).
EMA R2 validation was achieved in 2022. EMA R3 validation was achieved in 2024. These are not marketing certifications. EMA validation is a technical verification conducted by the regulatory body that receives the submissions. It confirms that eCTD Radar produces output meeting the EMA's technical specification — format, structure, XML architecture, and controlled vocabulary.
Software that has not completed EMA validation has not been tested against EMA's technical requirements. Submissions from unvalidated software may contain errors invisible to the regulatory affairs team — but flagged at the authority's submission gateway.
eCTD Outsourcing Book a DemoWhat eCTD Radar does
Dossier Compilation
- Module 1–5 building and structure management
- Automated XML backbone generation (v4 and v3.2)
- PDF bookmarking and hyperlink validation
- STF (Study Tagging Files) support
- Pre-submission technical validation
Lifecycle & Sequence Management
- Full sequence history across initial, variation, and renewal submissions
- Lifecycle tracking: superseded documents, replaced files, leaf attributes
- Multi-authority output: SFDA, EMA, EDA, MOH/DHA, GCC
- Module 1 regional documents adapted per target authority
- Deadline reminders for renewal and variation windows
Validation & Infrastructure
- EMA R2 validation (2022) and R3 validation (2024)
- Validation reports generated pre-submission
- Full audit trail with complete version history
- Secure cloud archive and full data export
- 24/7 access — no installation required
Built in-house. Validated externally. Used in production.
eCTD Radar is built and maintained by EMCO Egypt's software department — the same team that runs our eCTD outsourcing operations. The software is updated by people who are actively submitting dossiers to SFDA, EMA, and EDA. When a new authority-specific requirement changes the technical format, the update comes from the team that is already making that change in live operations.
For organisations using our eCTD outsourcing service, eCTD Radar is the operational platform. For organisations wanting to run their own eCTD submissions in-house, eCTD Radar is available as a direct licence. For teams building their eCTD competency, eCTD Radar is the software used in our eCTD training programme.