Case Study

Contamination Control: Generation of a Contamination Control Strategy

A small-scale parenteral nutritional compounding facility in Europe engaged CAI to support remediation efforts required by its local Regulatory Authority. The client site had been...

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Building Excellence in Pharma Manufacturing Through Rigor
E-Publication

Building Excellence in Pharma Manufacturing Through Rigor

In the life sciences industry, excellence is not optional—it’s imperative. The cost of non-compliance is measured not only in dollars and delays but in patient...

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Environmental Monitoring Performance Qualification (EMPQ) and Validation Support Services
Case Study

Environmental Monitoring Performance Qualification (EMPQ) and Validation Support Services

In early 2022, CAI was approached by a rapidly growing pharmaceutical/biotech company to qualify a new series of aseptic processing rooms.

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Laboratory Equipment Qualification Process
Case Study

Laboratory Equipment Qualification Process

A client was upgrading their laboratory for a new product release. Due to CAI’s experience and expertise, our team members knew that they could not...

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SAP S4HANA Implementation
Case Study

SAP S4HANA Implementation

The client, a large multinational pharmaceutical company, is implementing a new global ERP (Enterprise Resource Planning) system, SAP S4HANA, and needed an experienced professional to...

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MDR Compliance Project
Case Study

MDR Compliance Project

CAI started its collaboration with the client in 2019 originating from personal contacts of CAI agents. During this time, CAI delivered more than 350k€ of...

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Aseptic Expertise and Delivery of Services
Case Study

Aseptic Expertise and Delivery of Services

In February 2024, CAI was approached by a leading pharma industry services company that provides solutions including end-to-end drug development, clinical trial services, and commercial...

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The Problem with Construction Quality
E-Publication

The Problem with Construction Quality

Quality management in the mission critical construction industry is underperforming. The reader need look no further for the evidence to support this assertion than to...

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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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