Dossier preparation, production, submission and maintenance

Wednesday 16 March 2011 Outsourcing electronic submission filing: From strategy to training, from consultancy to services


How a dermatology company implemented eCTD while centralizing the management of publishing activities and outsourcing eCTD production.


CLIENT


  • A mid size pharmaceutical company.    
  • Department: The global regulatory affair.

CONTEXT


Publishing and submission are managed from 3 different sites with many variations. The company wants to achieve a centralized creation and management of all submissions worldwide, following an "eCTD minded" approach.


OBJECTIVES


  • Analysis of the as-is situation. Challenges on the today strategy.
  • Definition of the tools required and training action.
  • Evaluate externalization options (submission, variations…).

ORGANIZATION OF THE MISSION


Strategic consultancy:


  • Challenge the actual situation. Identify the risks. Identify key questions.
  • Set up the training needs and the training programs. Select the appropriate software tools. 

Outsourcing Services:

 

  • Analyse eCTD issues. Train the internal team on the new tools and new processes.
  • Propose the outsourcing of the submissions and variation files (according to the identified needs).

RESOURCES


  • 1 senior consultant in regulatory tracking.
  • 1 English speaking confirmed consultant with scientific background.
  • 1 regulatory affairs expert responsible for the delivery.

 

RESULTS


  • A new strategy on publishing and events tracking: all related activities centralized, performed internally for strategic products, outsourced for older/not strategic ones.
  • Internal resources trained (specific team) and following a new formalized process.

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