Reference Projects

Current projects (selection)

  • Multi-project management to increase production performance by reducing of transfer times (biotechnology)
  • Agile project management in the context of the implementation of a CAPA
  • Designing of clean room area for clinical reproductive medicine (building and technical equipment) including qualification
  • Management of complaints and deviations, root cause analysis, implementing CAPA’s in a production company of disinfections
  • Engineering & planning for the integration of equipment into a new building: facility layout, hygiene design, material/personnel flows, negotiations, management of all specialist planners

Completed projects (selection)

  • 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)

 

Our Clients (Selection)

Boehringer Ingelheim
CSL Behring
Schülke & Mayr GmbH
Octapharma GmbH

PAV

 

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