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Friday 09 July 2010

Business Cases

Variations: treatment in international context Friday 20 February 2009

Client:

A world leader in pharmaceuticals, International Regulatory Affairs Department.

 

Context:

Delay in the processing of several hundred variations on international marketing authorisation (MA) files.

 

Objective:

To make good this delay to ensure continuity of regulatory obligations within the industry before the controlling authorities in countries of exportation.

 

Organisation of task:

• To obtain the elements requested in each variation (documents, samples, packaging, legalisation processes etc.).

• To place these elements in envelopes for sending to each country concerned (83 in total).

• To enrich the centralised database for monitoring the regulatory activities (regulatory tracking).

 

Resources applied:

• 4 people in in-sourcing for 4 months, all BAC+5 diploma holders in foreign languages.

• Time taken to introduce the task just 5 weeks, within a complex work context.

 

Results:

Objective realised within the planned time. Client was very satisfied with the service, which favoured new requests for assistance.