Making the new Healthcare regulations an opportunity in serialization!

We helped a Fortune 500 pharma distribution organization in preparing for Track&Trace / Anti-Counterfeiting Regulations.
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Overview

In one of the top pharmaceutical company we translated new coming regulation into a clear roadmap which aligned everybody on the key milestone, labelling, and process requirements.

Client profile

Large multinational health care company listed among the Fortune 500. Active in three sectors, it manufactures and distributes medical devices, pharmaceutical products and consumer packaged goods.

Challenge

Our client wanted to be compliant regarding law regulation but also ensure traceability while maintaining packaging/warehousing efficiency.
Mains challenges were the increase of high risk repack given tamper evidence and traceability requirements and the SKU segmentation which implied country specifics, multi country, standard export. Consequences were needed to be taken into account such as the impact on quality and reverse logistics: sampling, return and destruction

Solution

Our project head designed along with his team a project management structure, governance and discipline for the entire project delivery.
A special attention was also given to change management, and coherent transformation around process, organization and systems
Finally a project management office dedicated to the implementation phase led the operational details & specifics, while ensuring on-budget/time delivery.

Results

A practical roadmap aligned with regulations and business priorities was the source of a consensus around the chosen “Traceability” solution and its pros/cons.
Bluecrux was also able to deliver an articulated business case around phased investments, savings and costs, supported by fact based assumptions.
Finally bluecrux ensures the quality of the total delivery by appointing a dedicated PMO during the implementation.

Contact Us

Koen Jaspers, Partner +32 (479) 30 13 41 e-mail me