Welcome to eCTD Submit

Customer-focused regulatory submission services

Whatever the challenge we’ll ensure you meet your goals

We are dedicated to providing the same outstanding quality of service across all electronic submissions, be it a IND submission, a biologics license application (BLA), conversion to eCTD format or simply the maintenance of an existing application.

Your international partner

Our global presence and international network of publishing experts means we are perfectly placed to meet your needs in the US, Canada, Europe and elsewhere.

  • eCTD submission outsourcing
  • eCTD lifecycle management

    We provide continued support for all future sequences of your application.

  • ESG for FDA & Health Canada

    We securely transmit to FDA or Health Canada using the authorized submission portal.

  • Conversion of DMFs to eCTD
  • Regulatory writing and review

    Our medical writers and MDs can author your regulatory documentation.

  • Regulatory affairs & operations

    We provide regulatory project management and operations support as a matter of course.

  • Staff augmentation

    If you are short-handed we can provide additional regulatory support at most levels. We supply ad-hoc staff members who are fully trained and ready to increase your deliverables. They can work with you ‘on-site’ or remotely.

  • Regulatory strategy consulting
  • Document level publishing

    We prepare documents for publishing by optimizing templates, hyperlinking, bookmarking, formatting and converting files to the necessary standards.

  • Document & submission QC
  • Labeling, advertising & promotional materials

    We provide SPL services, drug registration and listings, and 2253 submissions.

  • Legacy paper management and conversion to eCTD

    We deliver legacy paper submission publishing, NeeS and conversions to eCTD, including scanning services, record management, site closures and M&A document transfers.

  • Business process analysis, consulting and optimization
  • EU submissions
  • Outstanding software