Insights into Improvements: Building a Targeted Roadmap for ISO 9001 Aligned Optimization
Our client manages a global repository of biological data and conducts an annual certification process to ensure...
GMP Audit Readiness for CGT Operations
Brevitas was engaged to conduct an audit-readiness assessment using a risk-based approach to identify compliance gaps and...
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...
GMP Drug Manufacturing Policy Development
Our Drug Manufacturing Client is currently in Phase 3 Clinical Trails. They retained the services of the...
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...
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...
Effective Project Management Helps Alleviate Compliance Issues and Production Backlogs
In order to meet increasing demands for their product, our global pharmaceutical client retained the services of...
