Case Studies: Compliance & Regulatory Issues

Regulatory Support and CTD Writing for Tech Transfer Project
Case Study

Regulatory Support and CTD Writing for Tech Transfer Project

Following the acquisition of a range of injectable products, and in order for our client to be operationally ready for commercial production under their own...

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Streamlined Deviation Process Flows
Case Study

Streamlined Deviation Process Flows

A leading cell and gene therapy company needed to stabilize site operations and optimize site improvement activities. Specifically, the site sought to improve its deviation...

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