ELECTRONIC DOSSIER (eCTD) PREPARATION AND SUBMISSION

Get your dossier submitted faster, cleaner, and with fewer risks
We help pharmaceutical companies prepare and submit eCTD dossiers smoothly — without technical headaches, delays, or unnecessary refusals.
What you get with us:

• Full eCTD preparation of the dossier
• XML transformation through the official MOH-approved program
• Fast electronic submission via MOH systems
• Support with e-signing and machine-readable Power of Attorney
• Automated pre-submission error checking (validation)
• 24/7 secure storage and access to all documents
• Strict quality control that significantly reduces the risk of rejection
• Full technical support during submission and responses to authority requests

Timeframes and cost depend on the volume of your data - we always provide a transparent calculation in advance.
Leave a request for a free consultation - and let’s move your product forward without unnecessary delays.
Your drug. Our expertise. Seamless registration.