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
  • Training

Airflow Visualization Study to Address Audit Observations

Our client, a CDMO in the biopharmaceutical industry retained the services of the Brevitas team to help...

Validation Framework and Data Integrity Program for CGT Non-Profit Organization

A Non-Profit Organization creating cell and gene therapies was looking to improve their CSV, CQV, and data...

Serialization and Aggregation Readiness for US Products

A Global Pharmaceutical client required implementation of aggregation functionality for their packaging lines as part of the...

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 Contract Lab Testing Client retained the services of the Brevitas team to provide them with support...

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...