Reference Projects

Current projects (selection)


  • Project consulting and contract coordination for a new reprocessing unit of medical devices (CSSD)
  • Coordination of a transfer project from initialization, production of the validation batches incl. packaging, support of the client during the entire registration process to the first commercial delivery (first-wave-launch)

  • Clean room planning and planning of climate chambers including qualification
  • Validation of the infrastructure for clean media, cleanrooms and monitoring

  • Project management and management of the planning phase of the new construction of a Solida production facility

  • Design clean room area for clinical reproductive medicine (building and technical equipment) including qualification

Completed projects (selection)

  • Management of complaints and deviations, root cause analysis, implementing CAPA’s in a production of disinfection’s
  • Engineering & planning for the integration of equipment into a new building: facility layout, hygiene design, material/personnel flows, negotiations, management of all specialist planners
  • Multi-project management to increase production performance by reducing of transfer times (biotechnology)
  • Agile project management in the context of CAPA implementation
  • Consulting for the expansion of production capacities (overall project coordination, engineering, procurement and qualification)
  • Project management during the design phase of site consolidation on client side (leading pharmaceutical manufacturer)
  • Advice on efficient production processes and equipment and optimization of clean room processes (sterile tunnel/ isolator) incl. translation into process flow diagram
  • Advice on modern production methods, GMP requirements, clean room and equipment concept
  • Project management in the construction of a new QC laboratory (all project phases), including cost and schedule control
  • Project management for the upgrade of an existing supply of pure media (production, storage, distribution) on the client side (leading pharmaceutical manufacturer)
  • GMP compliance support to a manufacturer of special devices for sterile filling
  • Preparation of all planning and tendering documents, including preparation of risk analysis for critical pure media
  • Coordination of the technical and organizational measures for the production of certified mouth-nose protection masks
  • Project management for a contract manufacturer upgrading its solid production
  • Feasibility study for the implementation of a sterile production in an existing building (testing for material and personnel flow and hygiene zones, incl. supply technology for high purity media and air conditioning)
  • Containment process consulting for the upgrade of the production of hormone products for a leading international manufacturer
  • G+Q Lead and process consulting for the upgrade of a sterile filling line (planning and realization)
  • Development of a concept for the parallel production of drugs and non-medications (process technology, operating and hygiene concept)
  • Creation of an overall site concept for worldwide supply (incl. U.S.) of the entire product portfolio (identification of all necessary measures for a successful implementation)
  • Feasibility study for the expansion of the production of a contract manufacturer in the area of hormone production (user requirements, room program, process flows, cost estimation)