eCTD Dienstleistungen

Hier können Sie nach Anbietern für eCTD Dienstleistungen suchen. Die Liste erhebt keinen Anspruch auf Vollständigkeit und es kann keine Gewähr für die Richtigkeit und Aktualität der zur Verfügung gestellten Informationen übernommen werden.

Sollten Sie selbst Anbieter von Dienstleistungen in diesem Bereich sein, haben Sie die Möglichkeit, sich kostenfrei in dieses Verzeichnis einzutragen.

Saidia Pharma Service Limited

Bei den Mühren 66a

20457 Hamburg



  • eCTD Management
  • Baseline Erstellung

Riegler & Klar Pharma-Consulting GbR

Berliner Str. 133

14467 Potsdam



  • eCTD Service inklusive Erstellung von Baseline eCTDs
  • Umformatierung von Zulassungsdossiers (NtA in CTD Format bzw.CTD in NeeS und eCTD-Strukturen)

Flaig Pharma Consulting

Dr. Karl-Heinz Flaig

Josef-Weigl-Straße 1

82041 Deisenhofen bei München



  • Kompilieren des Arzneimittel Dossiers in das electronic Common Technical Document [eCTD] Format für die elektronische Einreichung

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

Diapharm GmbH & Co. KG

Hafenweg 18-20

48155 Münster



  • Komplettes eCTD Management
  • Baseline eCTD Erstellung
  • Umformatierung von Dossiers: NtA > CTD und CTD > eCTD

Eisinger Submission Management

Kirchweingarten 14

A-2102 Bisamberg



  • e-Readyness von Dokumenten
  • Erstellung von eCTDs und NeeS
  • Umwandlung von Papier-, NtA and NeeS-Format zu eCTD
  • Erstellung von Baseline Dossiers

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


pharmadocs GmbH & Co. KG

Untere Gartenstr. 7

96231 Bad Staffelstein


T: 09573 26396-0     


Unsere Leistungen: 

  • Erstellung, Validierung und Einreichung des Zulassungsdossiers im eCTD-Format
  • Umformatierung in eCTD
  • Erstellung einer eCTD Baseline
  • Pflege des eCTD-Dossiers im Life Cycle Management
  • Digitalisierung der Papierdokumente


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

DocShifter N.V

Kortrijksesteenweg 1144B, 


Gent, Belgien



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)


Beratungsgesellschaft für pharmazeutische Unternehmen mbH

Am Mittelhafen 20

48155 Münster 


Tel:  +49 (0) 251 60939-10



  • Erstellung von Baseline eCTDs
  • Erstellung von eCTDs und NeeS
  • Umwandlung von Papier-, NtA and NeeS-Format zu eCTD
  • Erstellung, Validierung und Einreichung des Zulassungsdossiers im eCTD-Format 
  • Digitalisierung der Papierdokumente 

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.

  • Bearbeitung von Dokumenten zur eCTD Einreichung
  • Durchführung elektronischer Einreichungen aller Produktstationen
  • RIMS