Manufacturing Science & Technology

While bringing newly developed innovative products towards the subsequent phases in life sciences product development cycle, small-scale batches are produced to supply clinical studies and process validation activities. Part our manufacturing science and technology activities encompass proof of concept studies, process characterisation, process analytical technology (PAT) solutions, technology transfer strategies, process validation and technical documentation.

Our consultants apply a data-driven and proactive decision-making process enabling our partners to tackle the development cycle more efficiently. 

Our expertise in Manufacturing Science & Technology entails the following: 

  • Process familiarisation – Proof of Concept
  • Process Characterisation / Design of Experiments (DoE)
  • Site-to-Site Tech Transfer
  • Scale-Up Tech Transfer
  • Verification, Commissioning & Qualification
  • Process Validation
  • Reliability & Asset Performance Management
  • Operational Excellence
  • Outage Planning & Management
  • New Facilities Preparation: compliance expertise during the design phase, design review and assistance in presenting the design to the FDA
  • Preparation for Regulatory Inspections: perform mock inspections followed by preparation for inspections; implementation of action plans to address deficiencies and regulatory risk