Arema

eCTD publishing and outsourcing

Streamline your submissions to Health Authorities in Tunisia and the GCC with our expert eCTD publishing support. 

We provide end-to end electronic submission services to help your company meet technical and regulatory requirements with accuracy, efficiency, and compliance. 

Whether you are preparing a new submission or managing the lifecycle of an existing dossier, we offer flexible and reliable solutions tailored to your regulatory needs. 

Our core services include: 

  • Compilation and publishing of regulatory submissions in eCTD format 
  • eCTD validation, quality control, and compliance checks 
  • Definition of CTD structure and granularity for regulatory dossiers 
  • Submission-readiness assessments and regulatory gap analysis 
  • Preparation of eCTD-compliant documentation 
  • Project management and lifecycle maintenance of regulatory submissions in Tunisia and GCC regions 
  • Electronic submissions via national regulatory portals