eSubmission Typical Systems

 e-DRA Project References
Implement and roll-out global eCTD system, project coordination for system vendor (Top 3 Pharma)
Migrate US legacy eSubmissions to new eCTD system - project coordination for system vendor (Top 3 Pharma)
Select, implement validate eCTD system (Regulatory Service Provider)
Support selection eCTD system (CRO)
Implement system and adapt business process to submit eINDs to the FDA (Biotech Company)
Support eCTD compilation of DCP (Top 20 Pharma)
Analyse eCTD document re-use process (Generic Pharma)
Implement Veterinary NeeS eSubmission system (Animal Health company)
Implement eCTD System (Top 20 Pharma) 

Einsatz eines Dossier-Management Systems in der Arzneimittelindustrie / Auswahl, Einführung und praktische Erfahrung
Pharmind 2003. 65: 511– 519, Kainz A, Harmsen S.
This paper describes the experience of Fujisawa GmbH, Munich (Germany), prior and following the installation of an electronic publishing system (dossier management system). It states reasons for investing into such a publishing system. The evaluation criteria and the implementation plan for such a system are examined, hurdles that had to be overcome during the first electronic compilation of a Marketing Authorisation Application are described. The authors discuss the challenges and limits of being compliant with the eCTD guideline and inform about the lessons learned.

Realizing eCTD and EDMS benefits
22-24. September 2009, Warsaw - userBridge
Further information at

Case Study: Select, Implement, and Validate an eCTD Management System
29. October 2008, Munich - Regulatory Symposium
More information at http://www.ndareg,com

Auswahl und Einführung eines eCTD Managementsystems
26. / 27. August 2008, Berlin - Effizientes Regulatory Document Management
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Moving away from the paper-based submission model - how to change business processes &
organisation to benefit most from eCTD
September, 2007, Nice - Userbridge - Docubridge User Conference
Further information at

How to keep track of all documents and dossiers when submitting eCTDs
February, 2007, Paris, Informa Life Science, Lifecycle Management of the eCTD

Faster, Superior, More Cost Effective: Has the eCTD Delivered Its Promises? Keeping Up with Ever-changing Regulations in All Regions
June, 2006, Philadelphia, 42nd Annual DIA

Implementing an eCTD system at a global pharmaceutical company (Systems / Technical point of view)
May 2010, Mannheim - eCTD 2010 - 10 years of eCTD, Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.
More info at