Case Studies
Performance Dashboards Development
A biotech company, preparing to launch its first drug batches, needed to implement performance measurement. CAI's global team helped identify key KPIs and built a...
Read MoreContamination 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...
Read MoreDeveloping a Project Management Office at a Small Manufacturing Site
DEVELOPING A PROJECTMANAGEMENT OFFICE(PMO) AT A SMALLMANUFACTURING SITE Download the PDF PROJECT OVERVIEW CAI transformed an under-prioritized pharmaceutical site into a strategic asset by designing...
Read MoreE-Publications
Developing Effective Procedures
Needing to develop or update your procedures? Are you sitting at your computer starting to write procedures for every subject discussed in regulations and standards,...
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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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Revolutionize Technical Summarization With AI-Driven Precision
Technical summarization in regulated industries presents a significant challenge. The process is crucial yet often burdensome, requiring meticulous attention to detail and strict adherence to...
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Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect...
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EU GMP Annex 1 Compliance: Global Requirements & PIC/S Alignment
The 2023 revision of EU GMP Annex 1 reset the global standard for sterile manufacturing. It expands the guidance, tightens contamination-control expectations and aligns requirements...
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WINDSOR FRAMEWORK: WHAT IS IT?
The Windsor Framework (WF), which came into effect on January 1, 2025, is a significant agreement between the UK and the EU that replaces the...
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