Regulatory Affairs

We provide a full dossier review and eCTD publishing service. We can assess old dossiers and provide a Gap Analysis and then update your dossier to be compliant and ready for submission.

We manage all your eCTD conversions, when you do not have time or resources to do so, delivering a complete dossier in electronic format, using the most reputable software the market has to offer.

Electronic Common Technical Document (eCTD)

This is the interface used in the pharmaceutical industry to transfer regulatory information to the Agencies. The content is based on the format of the Common Technical Document (CTD).

We can assist you in converting any previous frameworks to this new format:

  •  Notice to Applicant (NtA)
  •  Non-eCTD electronic Submissions (NeeS)
  •  Common Technical Document (CTD)

The following diagram shows the modular structure of the CTD:

eCTD publishing



From 1 February 2013, any submission that does not comply with the new eCTD validation criteria will lead to non-acceptance of applications by the EMA.

eCTD in the Centralised Procedure – The EMA now only accepts submissions received in eCTD format. Since January 2013 and “Mandatory from March 2014″ all eCTD submissions must be sent using the dedicated submission channels: eSubmission Gateway or the related eSubmission Web Client

Contact Us

If you are interested in our service please contact us for more information.

Telephone: +420 222 523 941

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