Our Services

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Content
  • Process
    Consulting

    A fast input for your business plan.

     

    OUR DELIVERABLES

    • Process step overview
    • Process description
    • Factory output overview
    • Cost overview
    • Time schedule overview

    YOUR BENEFITS

    • Fast delivery <1 week
    • Solid starting point for further steps

     
     
  • Conceptual
    Design

    The first step to realize your project, firm planning.

     

    OUR DELIVERABLES

    • Process flow diagrams
    • GMP-layout development
    • Equipment and room lists

    Determination of

    • Space requirements
    • Investment costs
    • Time schedule

    YOUR BENEFITS

    • GMP compliant workflow, layout and environment
    • One partner with in-depth knowledge of pharmaceutical processes
    • Structured planning process with defined delivery date
    • Reliable basis for investment decisions

     
     
  • Basic &
    Detailed Design

    Time to order equipment!

     

    OUR DELIVERABLES

    • Final design and specification of all trades in scope
    • Validation master plan
    • Risk analysis of critical systems
    • Proposal evaluation
    • Refinement of investment cost values and time schedule

    YOUR BENEFITS

    • One partner with combined in-depth knowledge of pharmaceutical processes and machine engineering
    • Consistent planning
    • Complete GMP production area out of one hand!
    • Immense reduction of implementation risks

     
     
  • Manufacturing &
    Construction Management

    One partner with full responsibility for realization.

     

    OUR DELIVERABLES

    Dedicated project manager for

    • Regular progress reports
    • Procurement support
    • Quality assurance inspections
    • Time schedule supervision for all trades of scope
    • In house and on site trade supervision

    YOUR BENEFITS

    • One partner with full responsibility for scope, function, and price
    • One project manager / contact person for all trades
    • Steer and manage one partner instead of multiple
    • Realization of suppliers interfaces in one hand
    • Major reduction of implementation risks!

     
     
  • Qualification &
    Validation

    GMP compliance, your success factor!

     

    OUR DELIVERABLES

    • Qualification
    • Documentation and execution of DQ / OQ
    • Support of PQ activities
    • Validation of
      - Manufacturing and cleaning processes
      - Analytical methods
      - Computer-based systems and automation

    YOUR BENEFITS

    • Fast track execution due to in-depth machine knowledge
    • Efficient approach to Design, Installation, and Operational Qualifications
    • Advanced Staff Trainings
    • Reduction of time to market