eCTD Publishing and eSubmissions :
Streamline your submissions to health authorities in Tunisia and the GCC with our expert eCTD publishing support.
We provide electronic submission services helping your company meet technical and regulaotry requirements with precision and efficiency. Whether you’re preparing a new submission or managing the lifecycle of an existing one, we offer flexible, reliable solutions to fit your needs.
If you have specific requirements, we’re happy to customize our services to support your regulatory goals.
Our core services include:
- Compilation and publishing of submissions in eCTD
- eCTD validation, quality control, and compliance checks
- Defining CTD structure and granularity for your dossiers
- Submission-readiness assessments and gap analysis
- Preparation of eCTD-compliant documents
- Project management and lifecycle maintenance of submissions within Tunisia and GCC regulatory frameworks
- Electronic submissions via national portals….etc
We are also partner of Extedo using their tools for publishing activities ( eCTD Manager®, EURS Validator®) and provides customer coordination & support for their regional clients.
If you have specific requirements, we’re happy to customize our services to support your
regulatory goals.