Case Studies

Get to know our work by exploring our case studies.

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  • Commissioning, Qualification & Validation
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  • Regulatory Affairs
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GMP Drug Manufacturing Policy Development

Our Drug Manufacturing Client is currently in Phase 3 Clinical Trails. They retained the services of the...

FT-IR Instrument Data Integrity Risk Assessment

Our laboratory Client retained the services of the Brevitas team to provide them with support to assess...

Autoclave Qualification to Achieve Regulatory Compliance

Our Cosmetic Client retained the services of the Brevitas team to provide them with appropriate technical documentation...

Sortation Code Upgrade Enhances Sortation Functionality & Efficiency

Brevitas took the lead in a Sortation Code Upgrade at two sortation hubs for a Global Logistics...

SOP Consolidation across Multiple Global Sites Promotes Move towards Lean Operations

Brevitas consultants provided technical and compliance expertise to a leading Canadian pharmaceutical company for the revision and...

Regulatory Inspection Preparation Addresses Key Compliance and Production Issues

After a few years of compliance issues, our Global Pharmaceutical client retained the services of the Brevitas...

Project Management of a Site-wide Walk-In Refrigerator Remediation Initiative

In order to upgrade their WIRs to GMP standards, our Global Pharmaceutical client retained the services of...

On-Site Evaluation (OSE) Preparation Facilitates Early Licensure of New Biological Drug

An international client required support to address recent findings from an FDA inspection and prepare for an...

LIMS Implementation Reduces Testing Cycle Times and Dramatically Cuts Costs

After years of paper-based laboratory testing processes, our pharmaceutical client was looking to make strides in a...

Global Document Management Solution Reduces Infrastructure Cost, Harmonizes Practices

The Brevitas team supported the replacement of three legacy systems with a global document management system that...