Publishing and eCTD Submission

eCTD is the globally recognized standard format for submitting regulatory documents to health authorities. All lifecycle management submissions, from investigational applications to marketing authorizations, must be submitted in eCTD format. With increasing demands for eCTD submissions and constantly changing regulatory requirements, eCTD publishing can be complex and expensive.

To overcome these challenges, eSA provides submission services worldwide. Our experienced team of regulatory affairs and operations specialists and eCTD publishing experts ensure efficient, timely, and compliant submissions. Our services can be customized to meet any specific needs, whether it is full-service regulatory operations consulting or occasional overflow support. With our deep knowledge of local and regional guidelines, eSA is the ideal partner for reliable and efficient regulatory publishing services..

Our support include:

• Submission services to health authorities over the world
• End to end services for Publishing and Submission
• Document Formatting and Publishing
• Preparing eCTD submission-ready document
• Validation and quality control of the eCTD
• Conversion from paper submissions to eCTD format

And more…