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Our experienced staff can assist your organisation with know-how and expertize towards cGMP manufacturing, design and compliance engineering.
With a team of professionals dedicated to the pharmaceutical, biotechnology and fine chemical industry, CDEng can provide your organisation with technical and regulatory solutions from design to validation.
  • We can help you both with scale-up of existing processes as well as new process designs.
  • We are aso skilled in optimisation and trouble-shoting of existing manufacturing plants.
  • We can offer services for your organisation where our personnel work as consultants independently or as part of a project team.
  • We can analyze and maintain GC / EI-MS & LC-ESI / MS

Services and competencies

  • Quality: by Design, Risk Management, Project Management and Quality support
  • Development of new manufacturing documentation and subsequent operator training and roll-out.
  • Documentaton (preparation, review and approval)
  • Verification and qualification of equipment (DQ/IQ/OQ/PQ)
  • Change control and non-conformity handling
  • Process and Cleaning Validation
  • Commissioning and manufacturing start-up
  • Maintenance and routines (SOP / LOP)

Technical expertise in areas

  • Water treatment systems (RO, ion exchange, filtration, UV, ozone, H2O2, etc)
  • Analytical methods
  • Risk analysis (FMEA, QRA, HACCP, HAZID, HAZOP)
  • Measurement technology
  • Process control and Automation
  • Systems of Milling/grinding and Dryers (rollers, mixers, centrifuges, fluidized beds, etc)
  • Small (kilo scale) to large (multi-tonne) scale manufacturing
  • Batch manufacturing equipment

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