eCTD Publishing and eSubmissions :
AREMA offers expert eCTD publishing and eSubmission outsourcing services, ensuring compliant and efficient regulatory filings with health authorities in Tunisia and across GCC countries.
Our eCTD publishing experts manage the entire lifecycle of your electronic submissions.
From the preparation of a new dossier to the lifecycle management of your existing submissions, including variations, renewals, extensions….etc we ensure the technical and regulatory compliance of every submission, with rigor and within the required timelines.
Our services are flexible and fully customizable, tailored to your company’s specific needs and regulatory objectives.
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.