Quality, Compliance & Operational Excellence

Compliance to Good Manufacturing Practices (GMP)

Quality, Compliance & Operational Excellence of pharmaceutical drugs

At Brevitas, we work extensively within the biologics and pharmaceutical industry. We have a thorough understanding of Good Manufacturing Practices (GMP) and recognize the importance it plays in maintaining the quality, compliance & operational excellence of our client's business.

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

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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

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

Manufacturing Excellence

  • Start-up Operations with GMP Controls
  • 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
  • Training & Coaching

Operational Excellence

  • Business Process Review and Optimization
  • Business Risk Assessment and Consultation
  • Business Planning and Management Consultation
  • Benchmarking
  • Continuous Improvement Project Execution
  • Organizational Change Management
  • Knowledge Management
  • Competency Model Development
  • 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.