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Effortlessly manage, publish and validate regulatory submissions

Publishing and maintaining regulatory submissions in compliance with varying regional standards is complex.

It often leaves regulatory staff feeling...

  • Struggling with processes, expertise, and infrastructure that won't scale
  • Swamped by the ever-increasing number of complex submissions
  • Stressed by regional regulatory requirements
  • Overwhelmed by the number of places that data is stored

We know how you feel and we don't want that for you.

Book a demo now to see how it will improve your business.

Book a personal demo now

Comply with regulatory requirements worldwide
Reduce product review, approval and delivery times
Minimize errors and increase productivity

See for yourself how effortless regulatory submissions can be

eCTDmanager streamlines end-to-end regulatory submission processes, enabling you to scale your operations and generate error-free, compliant submissions for any region of the world.

  • Simplify dossier assembly

    eCTDmanager provides a complete regulatory dossier assembly environment that enables you to handle electronic submissions without prior knowledge of XML technology.

  • Works with any common standards

    eCTDmanager enables you to build, view, validate and publish compliant submissions based on eCTD, NeeS, eCopy, IMPD, PIP, DMF, ASMF, and other regional formats.

  • Ensure submissions are technically valid

    The built-in validation technology is used by over 35 regulatory authorities worldwide and ensures your submission is valid according to the latest validation criteria.

  • Built-in lifecycle management

    Keep track of all changes and updates to your submissions.

So, book a demo now and see how effortless managing electronic submissions can be.

Some of our customers