eCTD Services

Here you can search for regulatory affairs service providers covering diverse services around eCTD und eSubmission.

The list does not claim to be complete and no guarantee can be given for the correctness and up-to-dateness of the information provided. Furthermore, please note that this list does not have any recommendatory character.

Saidia Pharma Service Limited

Bei den Mühren 66a

20457 Hamburg



  •     eCTD Management
  •     Baseline generation

mikle-pharm GmbH 

Dr. Michael Klein 

Sandgasse 17

76829 Landau 



  • Co-ordination of e-CTD initiative, baseline compilation and variation packages
  • Compilation of Baseline dossiers

Michor Consulting and Trade Services GmbH

Schönbrunnerstrasse 238/2/6

1120 Wien



  • Validate and select your software
  • Compile eCTD and NeeS submissions
  • Transition from paper to eCTD
  • Prepare electronic submissions

Eisinger Submission Management

Kirchweingarten 14

A-2102 Bisamberg



  • e-readyness of documents
  • compilation of eCTDs and NeeS
  • conversion from paper, NtA or NeeS format to eCTD
  • baseline dossier compilation

Diapharm GmbH & Co. KG

Hafenweg 18-20

48155 Münster



  • Complete eCTD management
  • Baseline eCTD preparation
  • Dossier reformatting: NtA > CTD and CTD > eCTD

ProPharma Group GmbH

Siemensdamm 62

13627 Berlin

Telefon: 030/856 06878-0


ProPharma Group GmbH is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare.

Contact us in any phase of your product's lifecycle if you are looking for a partner in Product Development, Regulatory Affairs, (Pharmaco)vigilance or QA/QC. 

  • Dossiercomplilation in customer databases or own
  • Data Management & IDMP

ERA Consulting GmbH 

Lange Strasse 70 

29664 Walsrode


Tel: # 49 (0) 5161 9890 0 

Fax: # 49 (0) 5161 9890 18   


ERA Consulting is a strategic regulatory consultancy for products such as vaccines, personalised medicine products, novel mAb's, biosimilars, complex proteins, cell and gene therapies, gene editing, regenerative medicine and NCE’s. ERA’s expert consultants are providing support ranging from strategic input, agency interactions, through to the management and writing of dossiers for marketing authorisation and electronic submission and interactions with various regulatory agencies such as EMA (including all National Agencies), FDA, PMDA, TGA, Health Canada and Swiss Medic.


  • Compilation, submission and coordination of eCTD dossiers (EU, US, Australia), e.g. MAA, IND, BLA, NDA, DMF, ASMF etc.
  • Preparation of eCTD baseline submissions
  • Compilation of NeeS dossiers
  • eCTD life-cycle management, including post-approval variations, amendments etc.
  • Preparation of eCTD ready documents and PDF files

DocShifter N.V

Kortrijksesteenweg 1144B, 


Gent, Belgium



DocShifter is a software solution that takes all your digital content (Office documents, images, PDF, etc.) and transforms it into technically compliant PDF (for FDA, EMA, PDMA, etc.). Do you need format transformations in the context of submissions, data or document migration, digital archiving, correspondence management or data extraction for IDMP?


We connect to all your enterprise systems for document management, regulatory information management, quality management and many more. Centralizing this process ensures harmonization, reduces risk and cost.


File transformations include but are not limited to: PDF, PDF/A, Word, TIFF, JPEG. DocShifter transforms thousands of documents 10x faster and at higher quality than comparable solutions. Speeding up your submission process.

  • Create fully technical compliant PDF's for any region (FDA, PMDA, EMA and many more)
  • Extensive document enrichment: PDF merging, font embedding, hyperlinking, splitting, pagination, watermarking, header & footer, advanced bookmarking and much more. 
  • Automate correspondence tracking by harmonizing all incoming communication with health authorities.
  • Automating form completion
  • Fast (no need for native applications). 
  • Reduced TCO. Lower licencing & infrastructure costs.
  • Neutral. Connect all your enterprise applications (DMS, RIM, etc.) and centralize.
  • Simple. Easy to use, implement and maintain.
  • Runs on all platforms (Docker, UNIX, Windows)

PharmaLex GmbH

Harrlachweg 6

68163 Mannheim




PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.


We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.


The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.

  •  Document processing
  • Full life cycle submission management
  • RIMS

Dr. Matthias Brunner,  Drug Regulatory Affairs Consultant

Hans-Bunte-Str. 8

69123 Heidelberg



  • Module 3/2.3 preparation in CTD/eCTD format, in required granularity for eCTD submission
  • Creation of EU ‘Baseline Dossier’
  • Transformation/re-formatting of legacy chemical-pharmaceutical documentation (e.g. paper/NtA/NeeS -> CTD; CTD -> eCTD)
  • Compilation of eCTD dossier (Module 3) – customer to provide access to eCTD document management software