Engineering and Science-based Operations

Create An Efficient and Robust Quality System

Make consistently compliant products using cost-effective manufacturing processes with built-in quality systems to improve the performance and compliance of your operation by:

  • Upgrading manufacturing and quality processes
  • Up-skill staff through competency based training programs
  • Interpreting regional and global standards and regulations
  • Developing operational, quality, and regulatory strategies
  • Implementing inspection readiness programs

We implement a unique methodology that aligns basic science with applied engineering. The result is the ability to consistently deliver high-quality products to customers faster and more efficiently.

The CAI Consulting Advantage

Our experienced consultants and integrated approach will help you:

  • Build a culture of innovation and continuous quality improvement
  • Implement science and engineering-based processes throughout your facility
  • Apply business and quality-risk management principles to improve your bottom line

Our Consulting Services

Product Realization Consulting

We improve your processes and product quality throughout the lifecycle. Beginning with initial concept development and refinement, our consultants plan a lifecycle strategy that ensures your products always meet customers’ needs.

We understand your needs often change as a product matures, including the need to move manufacturing operations globally and to reduce the cost of goods.

From pharmaceutical (OSD and sterile) and biopharmaceutical drug development to medical device manufacturing, we comprehensively address your product realization needs, such as product and process development, product quality lifecycle, etc.

Our Product Realization Consulting Services

  • Product development strategy definition
  • Product lifecycle management
  • Technology transfer (processes as well as analytical methods)
  • Data management strategy, planning, and management tools
  • Technical operations due diligence, technology assessment, and equipment selection
  • Process scale-up
  • Risk assessments and risk management planning
  • Development of process control strategy
  • Product and process characterization strategy
  • Cleaning and process validation strategy development
  • Method development and validation
  • Contract development organization selection and management

 

Quality and Regulatory

At Commissioning Agents, we create quality systems and raise quality awareness so you consistently deliver high quality products to your customers. We have met the challenges in developing, implementing, and sustaining efficient, effective, and compliant quality management systems for both ISO certification and worldwide GMP compliance. Effective quality management systems must be linked through procedures, tracking systems, approvers, and responsible parties. We are experts in implementing these systems in several industries.

In addition, we can develop a robust regulatory submission strategy, whether this is your first regulated product approval or you have a diverse product portfolio where you are balancing new product introductions with post-approval changes.

Our Quality and Regulatory Services 

  • Quality culture assessment, education, and deployment
  • Regulatory submissions and strategy (510k, PMA, NDA, BLA, IND, etc.)
  • Post-approval activities
  • Compliance remediation
  • Quality system development and improvement
  • Standards assessments including gap analysis
  • Supplier Quality Management program implementation
  • Auditing (cGMP, Supplier, Internal, Process)
  • Document management system assessments and implementations
  • Investigation and Root Cause Analysis program implementation
  • Quality Risk Management program deployment
  • Quality management review implementation
  • Stability program development
  • Inspection readiness
  • Assistance with FDA meetings (requesting, preparing for, and conducting)

 

Site and Manufacturing Operations

Once your process has been successfully implemented, we’ll prepare your organization for long-term success.

Keep your facilities running at peak efficiency with consistent Good Manufacturing Practices (GMP) by leveraging our engineering and operational expertise. Your plant can be the envy of your competitors—consistently efficient, reliable, and productive.

Our Site and Manufacturing Operations Services

  • Organizational assessment and change management
  • Safety and training program assessment and implementation
  • Leadership development, team building, and coaching
  • Value-stream mapping
  • Visual factory management and performance metrics implementation
  • Shop floor management
  • Facility asset management program
  • Space utilization optimization
  • Lean manufacturing implementation
  • Statistical process control program implementation
  • Knowledge, data and document management solutions
  • Maintenance program assessment
  • Building startup and process troubleshooting
  • Contamination and bioburden control strategy
  • Alarm management program implementation

 

Supply Chain

Supply chain risk management and efficiency are essential to profitability, satisfied customers, preserving quality of your products, and preventing drug shortages.

Supply chain risk management and operational success requires the right mix of technology, lean business systems, and critical analysis. And in today’s global business environment, access to current information from across your supply chain is critical.

Our supply chain experts help you analyze your processes and suppliers to ensure the quality of your product and achieve industry-leading supply chain performance, regardless of the scale of your operations.

Our Supply Chain Services

  • Track and trace implementation
  • Transportation, storage and distribution operation
  • Cost of goods (COGs) analysis and improvement
  • Cold-chain support
  • Long-term strategic planning
  • Drug-shortage mitigation
  • Contract Marketing Organization (CMO) evaluation, selection, and engagement
  • Third-party laboratory identification and management
  • Creation of quality agreements
  • Warehouse organization and optimization
  • Logistics planning, sourcing, and support
  • Shipping validation support
  • Enterprise Resource Planning (ERP)/Material Resource Planning (MRP) implementation

 

Owner’s Project Management

We provide experienced project support services to keep projects on track. You can be confident that even your most complex projects will be delivered on schedule and within budget.

Whether it’s facility or capital project needs, our ability to understand and integrate owner’s project requirements is unparalleled. We not only handle the construction quality and oversight aspects, we also handle the entire set of activities necessary to plan and coordinate shut downs, execute facility improvements, and start up using appropriate controls. Our proven experience will get your job done, whatever it takes. When your design and project are critical, we deliver success.

Our Owner’s Project Management Services

  • Project management
  • Clean facility design that meets regulatory requirements
  • Developing capital cost estimates
  • Schedules development and maintenance
  • Manpower estimates and resource schedule loading
  • FDA C level flow diagrams
  • Supplier selection assistance
  • Design review including GMP audit of design
  • Identify and management of long lead items
  • Procurement assistance
  • Site logistics planning
  • Owner meetings and management
  • Subcontractor coordination
  • Contract and resource management
  • Airflow and pressurization design and issues resolution
  • Developing capital financial strategy

 

 

TALK TO US » You’ll find out why we’re a premier name in Consulting and realize for yourself the value of working with an industry leader.