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.
- Documentation (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