Quality, Compliance & Operational Excellence

Compliance to Good Manufacturing Practices (GMP)

manufacturing of pharmaceutical drugs

At Brevitas, we work extensively within the biologics and pharmaceutical industry. We have a thorough understanding of compliance to Good Manufacturing Practices (GMP) and recognize the importance it plays in the ongoing success of our client’s businesses.

We provide a full range of expertise in quality assurance, quality system management, technical services, and operational excellence. During the course of our engagement, we continually educate your team to facilitate knowledge transfer and ensure long-term sustainability of quality enhancements.

Sustainable Improvements

consultant pointing out important statistics

Understanding and analyzing the existing business processes of organizations is a precursor to implementing viable change and enhancing performance. Our goal is to work with our clients to achieve their business objectives through sustainable improvements.

Relevant Expertise

team of consultants discussing project in a board room

Our consultants have experience that ranges from simple redesign of a single process in a single functional area to complex reengineering of all strategic, value-added processes within the organization. Our breadth of expertise with a wide variety of improvement tools ensures that the improvement efforts are solution-focused to attain our clients’ individual needs. We assist our clients in successfully managing and sustaining practices, processes and/or technology changes. Our consultants have effective relational and communication abilities to really empathize with our clients and reduce their anxiety for change.

What Gets Measured, Gets Done

team of consultants working together

We support our clients to achieve successful outcomes by providing services that assist their organization in developing frameworks and metrics, planning, and delivering operational efficiencies and excellence.

Quality, Compliance & Operational Excellence Services

Quality Assurance & Management


  • Document Management
  • Deviation Management
  • Quality Risk Assessment
  • Quality Technical Agreement
  • Change Control Management
  • Annual Product Quality Review
  • CAPA Plans/Effectiveness Development
  • Complaints Management
  • Vendor Management

Manufacturing Excellence


  • Set-up, Assessment & Enhancement of:
    • Facility Design
    • Sterile Manufacturing Operations and Aseptic Practices
    • Analytical Methods
    • Environmental Monitoring
  • Media Fill Validation
  • QC GMP Laboratory Practices
  • Lot Release per Market Authorization
  • Stability Program Review
  • Sterility Assurance Review
  • Start-up Operations with GMP Controls
  • Training & Coaching

Organizational Excellence


  • Business Process Review and Optimization
  • Continuous Improvement Project Execution
  • Benchmarking
  • Competency Model Development
  • Organizational Change Management
  • Knowledge Management
  • Dashboards & KPI Development

Let's Get Started!

Our expert consultants will guide you step-by-step through the process of achieving tangible results and long-lasting improvements.