Accelerating GMP Readiness Through Risk-Based CQV and Strategic Execution
Brevitas deployed a risk-based CQV strategy leveraging GxP test prioritization, clear system boundaries, leveraging commissioning data, proactive...
Regulatory Readiness: Brevitas’ Targeted Strategies for GMP Qualification of 50+ Benchtop CGT Systems
The Brevitas team developed and executed protocols for the qualification of over 50 benchtop CGT systems for...
Driving Efficiency: Streamlining the Qualification of 15 BSCs with QRM, Project & Vendor Management
Brevitas streamlined the qualification of 15 Biosafety Cabinets (BSCs) by applying Quality Risk Management (QRM) principles and...
Airflow Visualization Study to Address Audit Observations
Our client, a CDMO in the biopharmaceutical industry retained the services of the Brevitas team to help...
Serialization and Aggregation Readiness for US Products
A Global Pharmaceutical client required implementation of aggregation functionality for their packaging lines as part of the...
Autoclave Qualification to Achieve Regulatory Compliance
Our Cosmetic Client retained the services of the Brevitas team to provide them with appropriate technical documentation...
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...
Effective Project Management and Execution of Facility Expansion
In order to expand to a 50,000 sq. ft. sterile manufacturing facility, our multinational Biopharmaceutical client retained...
Effective Project Execution with Minimal Disruption to Plant Operations
Brevitas’ dedicated professionals oversaw the commissioning of three strategic projects within the engineering portfolio for a leading...