Case Study

Process Documentation

Expert Assistance to Define and Implement Processes

The client was a large company moving into pharmaceuticals with limited drug development expertise and resources.  Because the client operated in a different industry area that is highly regulated, regulatory processes existed in the wider client business but could be applied in the pharmaceutical area.
The client required expert assistance to design and implement suitable documentation and regualtory processes and tools to support pharmaceutical development.  They wished to take advantage of existing infrastructure and process by integrating best pharmaceutical practice to produce an efficient solution.

Fulcrum conducted a full needs analysis looking at the clients’ in-house systems and process and reviewed their existing business model. Fulcrum then designed, prioritised and implemented an effective solution. These processes implemented included a complete Quality Management System meeting pharmaceutical requirements, but using synergies from the processes that were already existing in the wider business.

The client now has appropriate pharmaceutical processes and are developing these as a core business process, while applying synergies and knowledge from the wider business

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