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

Germany

info@saidiapharma.de

Homepage 

  •     eCTD Management
  •     Baseline generation


mikle-pharm GmbH 

Dr. Michael Klein 

Sandgasse 17

76829 Landau 

Germany

michael@mikle-pharm.com

Homepage

  • 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

Austria

office@michor-consulting.eu

Homepage

  • 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

Austria

kurt@eisingersubmissions.com

Homepage

  • 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

Germany

info@diapharm.de

Homepage 

  • 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

regulatory.de@xendo.com

Homepage 

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

Germany 

Tel: # 49 (0) 5161 9890 0 

Fax: # 49 (0) 5161 9890 18 

info@eraconsulting.com   

Homepage 

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, 

9051 

Gent, Belgium

hello@docshifter.com

Homepage

 

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)