Our process includes all steps for a smooth submission both of the entire dossier and the individual documents

Preparation of your documents

regardless of the format of the available source text (paper documents, scanned PDF, PDF files) into electronically editable Word formats.


Technical translation into the desired language(s)

Because the individual modules include different contents, all texts are allocated to appropriate native subject experts (pharmacists, medical practitioners, biochemists, chemists, pharmacologists, etc.) for the translation process..


  • Modul 1 Regional Administrative Information – medical practitioners, pharmacists
  • Modul 2 Nonclinical/Clincal Overviews and Summaries - preclinical research / clinical trial -
    pharmacologists / toxicologists, medical practitioners, molecular scientists / biologists,
    biochemists / chemists, pharmacists
  • Modul 3 Quality - biotechnology / manufacturing, analytical chemistry - biotechnologists,
    biologists, biochemists, chemists
  • Modul 4 Nonclinical Study Reports – preclinical research – pharmacologists / toxicologists,
    molecular scientists / biologists, biochemists / chemists
  • Modul 4 Clinical Study Reports – clinical trials – pharmacologists / toxicologists, medical
    practitioners, biochemists, pharmacists

Revision by an additional subject expert as the first quality assurance step

Use of specially developed software tools for quality checks
(completeness, numbers, product names, chemical substances, abbreviations, etc.)

Labelling-specific quality control
in module 1 includes the check for compliance with:

  • EMA QRD templates plus Annexes I–IV and Appendices I–V
  • EDQM Standard Terms
  • Non-standard abbreviations
  • MedDRA terminology
  • Excipients guidelines
  • Lay terms in PL
  • Blue-box requirements
  • Formatting in line with EMA QRD conventions


Layout of the translation in accordance with the source text

  • Template creation
  • Typesetting of tables and graphics, etc.


Producing the dossier in the CTD-/eCTD format

(can also be booked without a translation)

We check all documents and create an application dossier in the CTD-/eCTD format valid throughout Europe to ensure that all legal requirements for a valid application are satisfied. Thanks to the many years of experience of mpü together with orangeglobal, we are able to offer a comprehensive service package of translations and the planning and implementation of marketing authorisations for medicinal products. Of course, we also take on complete maintenance of existing documentation and, if required, the necessary reformatting into the CTD or eCTD format. 

Depending on how you would like to design the process or in what format the modules are present, the process stages for the individual modules can be flexibly combined.