Business Cases
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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