Business Cases
Monday 07 March 2011 Variations: management in international context
Preparation of an important number of variations dossiers in an in-sourcing configuration on the Customer site.
CLIENT
A world leader in pharmaceutical industry, International Regulatory Affairs Department.
CONTEXT
Delay in the processing of several hundred variations of international marketing authorization files.
OBJECTIVES
To catch up to ensure continuity of regulatory obligations within the countries of exportation.
ORGANIZATION OF THE MISSION
- To obtain the elements necessary for completing each variation dossier (documents, files, samples, packaging, legalization processes, etc.).
- To place these elements in containers for sending them to each country concerned (83 in total).
- To populate the centralized database for monitoring the regulatory activities (regulatory events tracking).
RESOURCES
4 people on an “in-sourcing” basis during 4 months, all post-graduated in foreign languages.
RESULTS
- A project launched in less than 5 weeks.
- Objectives completed within the forecasted schedule. Client was very satisfied with the service, which favored new requests for assistance.
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