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)
Risk analysis (FMEA, QRA, HACCP, HAZID, HAZOP)
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