Service Packages

ready to build

Ready to build

  • You provide eCTD compliant documents in PDF-format.
  • We build the eCTD sequences.
prepare and build

Prepare and build

  • We train you on to author eCTD compliant documents and provide you with templates if needed.
  • You provide eCTD compliant documents in PDF-format.
  • We build the eCTD sequences.
Full Service

Full service

  • You provice eCTD documents in MS Word format.
  • We convert your MS Word documents into eCTD complaint PDF's.
  • We build the eCTD sequences.
  • You can sit back, relax and wait for the finished eCTD sequences.

Requirements

More and more health agencies require companies to submit their dossiers in eCTD format. In EU, US and Canada this format is now mandatory for some types of dossiers. In Australia, Gulf region, Japan, Thailand, South Africa and Switzerland, it is optional to submit dossiers in eCTD format as well.

EU
The EMA and EU competent authorities published an eSubmissions roadmap. From January 1st, 2019 onwards all dossiers should be submitted in eCTD format for human pharmaceutical products or V-NEES for veterinary pharmaceutical products. CP, MRP and DCP dossiers should be submitted in eCTD format already.

US
The FDA requires companies to submit NDA, ANDA and BLA dossiers in eCTD format. From May 5th, 2018 onwards, eCTD format will be mandatory when submitting IND and master files.

CANADA
Health Canada accepts the following specified regulatory activities in eCTD format only: NDS, SNDS, ANDS, SANDS. They recommend to submit other types of dossiers in eCTD format as well.

requirements
Our Team

Our Team

We are happy to assist with your company’s eCTD related projects.

5 reasons to work with our team, or so to say “your team”:

  • Our knowledge is the key to make your project a success.
  • We make your CTD modules eCTD ready or advise you on how to make them eCTD ready yourself.
  • Of course, we build eCTD sequences for you too.
  • We know it is important to get all the details right.
  • We understand the importance of adhering to your schedule whenever possible.
In summary: SUBMISSIONS MADE EASY!

Valentyna, Esther, Kim, Candy, Mariola and Eveline

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