• Process and facility design to match User Requirement Brief
• Design in operability, constructability, maintainability and GMP
• Options explored with users and stakeholders
• Agreed option developed and costed
• GMP review and risk analysis

• Process and analytical design
• Process specification and procurement
• Facility and HVAC specification
• Qualification management (VMP, DQ, IQ, OQ)
• Contractor selection
• Project and construction management

• Fit with strategic objectives
• Manufacturing options
• Return on investment and sensitivity analysis

• Discussions and involvement with each stakeholder
• Align with project and strategic objectives
• Obtain sign off

Start-Up and Operations

• Capacity planning and optimisation
• Operational excellence
• Programme management
• Process & analytical development and transfer to manufacture
• Quality management system
• Manufacturing organisation and recruitment
• Licensing strategy, site master file and license application
• Production scheduling
• Product release (QP)