SERVICES

CORE SERVICES

Engineering

  • User’s requirements specifications
  • Feasibility studies and project budgeting
  • Auditing and technical consultancy on plants, process and equipments
  • Site layout definition and optimization
  • Concept design
  • Basic design
  • Detail design
  • Procurement assistance
  • Design review (e.g. value engineering, GMP review, HSE review)
  • Construction management
  • Safety management
  • Translation of technical documentation

Commissioning and Validation

  • Validation Master Planning
  • Design Qualification
  • Risk Management (Impact Assessment, Risk Analysis, FMEA)
  • Equipment and systems FAT witnessing and coordination
  • Support to the start-up of plants, equipments and services
  • On-site commissioning
  • Equipment and systems SAT execution and coordination
  • Instruments calibration
  • Equipment and systems qualification (IQ, OQ, PQ)
  • Re-qualification activity and periodic checks
  • Support to Process Validation

Consultancy and Management

  • Project Management
  • Project Scheduling
  • Budgeting and cost control
  • Technical expertise
  • Permitting
  • Technology evaluation and selection
  • Plant and System Troubleshooting
  • Calibration and maintenance planning
  • Vendors auditing
  • Energy auditing
  • Regulatory consultancy

TARGET MARKETS and MOST RELEVANT SKILLS

Target markets

  • Sterile products manufacturing facilities
  • Manufacturing plants for active pharmaceutical ingredients (API)
  • Manufacturing plants for high potency pharmaceutical ingredients (HPAPI)
  • Biological and biotechnological production facilities
  • Packaging and warehousing systems
  • Pilot plants and R&D laboratories
  • Advanced therapies and regenerative medicine
  • Diagnostic products manufacturing
  • Medical devices industry
  • Radiopharmaceuticals production and research facilities
  • Process optimization and automation
  • Energy Efficiency

Most relevant skills

  • “Bulk” product processing plants
  • Fill-finish processing lines
  • Packaging and serialization technologies
  • Air conditioning (HVAC) systems
  • Barrier isolator and RABS systems
  • Clean utilities (PW, WFI, CS, etc.)
  • Chemical, biological and radiological containment
  • Process automation
  • Energy optimization

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