Multi-national Pharmaceutical Company – A Journey to a Single Harmonized Regulatory Content Source Management Solution

Challenge

Strongly growing with global offices, the pharmaceutical client was increasingly challenged with the variety of Regulatory systems, document locations and processes across the different locations involved in the Submission processes, creating a system landscape that was very disjunct, non-scalable and costly to maintain, with several systems nearing their end-of-life.

A single harmonized Regulatory Content Source Management solution to serve more than 8,000 users was chosen and implemented, based on one of fme’s core partner business platforms in the R&D space.

Client

Multi-national Pharmaceutical Company

Partner

Technologies / Services

»The complexity of the program was quite under-estimated. But now that the system is in place we see an overall good user acceptance. In a survey that was conducted, more than two thirds of the users responded that the new system has improved how they manage submission source content, and for more than 80% it meets the various needs of their business area. This was a great success and a key step on our road to implementing a global regulatory document authoring and submissions management capability to ensure continued regulatory compliance.«

IT Manager for Regulatory Content Management

Multi-national Pharma Company

Case Study | Multi-national Pharmaceutical Company – A Journey to a Single Harmonized Regulatory Content Source Management Solution

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