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...
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...
Compliance Support Leading to Reduction and Closure of Quality Notifications
In order to meet the constant demand for their products, our Global Pharmaceutical client retained the services...
Deviation Management Addresses Key Compliance and Production Issues for Global Client
After dealing with ongoing compliance issues, our global pharmaceutical client retained the services of Brevitas to provide...