<img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=56875&amp;fmt=gif">

Clinical Supply Release Optimization

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

Set up a free consultation


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.
A Fortune 500 pharmaceutical company
Quality and Regulatory

2020-CS-Clinical Supply Release Opt_shutterstock_659320228-cropped


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


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.


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.

Contact Us!

Speak to a Life Sciences Compliance & Efficiency expert today!

get in touch
Free Process Improvement Plan for Life Science Companies