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Clinical Supply Release Optimization

A Fortune 500 pharmaceutical company releasing compliant clinical batches to global locations

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Clinical Supply Release Optimization Quality and Regulatory

project info


Pharmaceutical company  was experiencing increased complexity associated with releasing clinical batches to global locations and ensuring that released batches were fully compliant with all regulatory commitments.
Client:
A Fortune 500 pharmaceutical company
Category:
Quality and Regulatory

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DISCOVERY & DESIGN

Enterey consultants were brought in to support the client in leveraging Annex 16 requirements to streamline their clinical batch review processes.

IMPLEMENTATION

Our team developed detailed solution recommendations and a workable implementation plan. By collaborating with Project Management, Supply Chain, Quality and Regulatory functions, our team mapped the future state business process solutions. Enterey consultants also worked with multiple IT departments to define a technology strategy that would enable these new processes for long term sustainment.

RESULTS ACHIEVED

Our team identified all regulatory gaps, proposed solutions and gain alignment from the organization. All root causes were successfully identified and mapped through a series of in-depth workshops facilitated by Enterey consultants, and solutions were designed to be manageable for the teams to implement and execute. The final set of solutions was designed to ensure that our client could achieve 100% Quality and Regulatory compliance, while removing non-value added work, increasing visibility to clinical supply and decreasing average batch release lead time.

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