Streamline eCTD Submissions

Get it Right the First Time

Publis icon PUBLISH enhances our eCTD quality suite by offering you the ability to assemble and publish eCTD and RPS submissions more quickly and easily than ever before. You’re going to like what you see.

Over the course of the last two years, we’ve asked our user community about their pain points. They’ve responded with a resounding common theme:

“Give us an innovative, cost-effective publishing solution that’s easy to use and that integrates seamlessly with GlobalSubmit REVIEW™ and VALIDATE™.”

Done.

PUBLISH is designed to simplify previously complex tasks; tasks that required so many steps it was easy to become confused.  With PUBLISH, you can perform those tasks in fewer steps, thus reducing confusion and in the long run, time and effort.  PUBLISH gives publishers clear direction as to the best procedures for complying with ICH and regional authority guidance. It also offers the outstanding performance that our clients – including the FDA – have come to expect.

When it’s crunch time and you’re on the verge of submitting your eCTD, you want your submission to process as quickly as possible. We get it. That’s why we made PUBLISH fast – you’ll be surprised at how fast – and extremely user friendly.

Key Benefits of PUBLISH:

  • Build eCTDs in the final format FDA reviewers see them in
  • Generates compliant submissions for US, EU, Swiss Medic, Canada, and Australia
  • Shield publishers from having to remember detailed regional requirements
  • Prompt publishers to construct valid regulatory activities
  • Automatically assign titles based on your naming conventions
  • Automate handling of define .xml, Structured Product Labeling and European eAF
  • Detect and fix validation errors in PUBLISH using our industry standard validation engine
  • Provide tools to manage the status of both submissions and regulatory activities

Ready to streamline eCTD submissions? Contact us at 888-840-9580.