Are you eCTD ready?

  • Writing, submitting and maintaining Drug Product Files
  • Baseline eSubmissions (Modules 2.3 and 3)
  • From NtA, NeeS, CTD to eCTD
  • Validation and submission of eCTD sequences


Since 2019-01-01 only eCTD in the EU!
  • You have no time / no resources for dossier works?
  • You have old files and you need baseline eSubmissions?
  • You do not want to buy the necessary software yourself?
  • You want to publish via orangeglobal?


ToDos for eCTD-Readiness of your valuable Drug Product Dossiers

The use of the electronic Common Technical Document (eCTD) format has been mandatory since 1 January 2019 for all electronic submissions to all regulatory activities, incl. national variations. It is therefore time to make your documents eCTD ready.


orangeglobal supports you in being fully compliant and meeting all eCTD requirements

Our eCTD service to create or revise registration dossiers includes:

  • Creation and submission of eCTD sequences using our installed eCTD software (Extedo)
  • Creation of an eCTD baseline (reflecting the current data status of your dossier)
  • Consideration of regional requirements (EMA, CMDh and national authorities) and corresponding validation criteria
  • Reformatting of your volume of approved applications e.g. from NeeS to eCTD
  • Conversion of old-NTA dossiers to eCTD
  • Creation of eCTD sequences from existing DMFs / ASMFs

Additional services to support you:

  • Dossier updates (Quality Overall Summary, Non-Clinical Overview / Summary, Clinical Overview / Summary) in collaboration with the client
  • Variation management and eSubmissions (CESP, eSubmission Gateway, etc.)
  • Translation by our translation and language management into all desired target languages

orangeglobal group has more than 10 years of project experience in dossier management and eCTD creation.

Ask us for a non-binding quotation

Jana Wolkow
Regulatory Affairs Project Manager
medical globalisation
orange glo bal

medical globalisation provider GmbH
Frauenstraße 1
89073 Ulm
Fon: +49 731 954 95 - 511
+49 731 954 955 - 0
Fax: +49 731 954 95 - 910
E-Mail: jana.wolkoworangeglobal.(.)de

CEO: Harald Schmid
District Court Ulm HRB 1672
VAT-ID: DE147035118