C&Q / QA / QP / MDR

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C&Q / QA / QP / MDR

We support our clients in efficient commissioning and qualification activities, to ensure on-time system handover and start-up.

Our GxP qualified teams guide our customers through the full commissioning process and qualify equipment and rooms in compliance with the relevant regulatory guidance (e.g. cGMP / ICH / 21 CFR / ISO / SHE) through specific Quality Assurance Management. Additionally, we offer professional support from our QPs and specialists in drug and medical device compliance, as well as pharmacovigilance and regulatory affairs. Find more about these services here: 

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Services

  • Compliance concepts such as validation / qualification master plans
  • Preparation of C&Q documentation
  • Commissioning and handover
  • Standardisation project and Q-processes
  • QA for supplier and CMO management
  • Project quality management / document controlling
  • Execution of qualification and validation tasks
  • Laboratory - Commissioning
  • Laboratory equipment qualification
  • Onboarding and training organisation (internal and external)
  • QA and QP according to guidelines (e.g. cGMP / ICH / 21 CFR / ISO / SHE)
  • QA and QP for aseptic and non-aseptic production of biological and chemical APIs, excipients and drug products
  • Pre-qualification of contractors
  • QA gap and risk assessments
  • Compliance deviations and change management support
  • As-built documentation
  • TechTransfer QA Management
  • QA during all stages of the product lifecycle

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Our Case Studies

  • New Production Facility to Support the Manufacturing of Antibody-Drug Conjugate Medicines

    Our customer, a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics required a new production facility for antibody-drug conjugates.

  • Hydro-Electric Power Station Electrical and Automation Systems

    Our client required a full update of the hydro-electric power station control system to the latest technology.

  • Greenfield Expansion for Solids Dosage Form Medicines

    Our customer, a leading pharmaceutical manufacturer required a significant increase in capacity of solid dosage form medicines.

  • New Production Facility to Support the Manufacturing Monoclonal Antibodies (mAbs)

    Our customer a leading pharmaceutical manufacturer needed to increase the production capacity of monoclonal antibodies as bio-pharmaceutical drug substance using mammalian cell cultures.

  • Expansion of R&D Building with New Pilot Plant for Continuous Drug Production

    Our customer, a leading pharmaceutical manufacturer required a new pilot plant for continuous drug production.

Further Capabilities

  • Building Services

    Flexible and high performance building services that are dynamic and responsive to the environmental needs of our clients.

  • Consulting

    We offer expert, individually tailored consultant services to our clients in the feasibility stages of new facilities or processes, tech transfers and scale-ups.

  • Project Management & Controlling

    With our hands-on approach to project delivery strategies, our experienced project managers and their teams define and manage schedules, budgets and deliverables throughout the project lifecycle.

  • Facility Design

    We specialise in full facility design, integrating complex functional processes and laboratories throughout their entire life cycle.

  • Process Engineering

    We understand our clients’ operational and quality process needs, applying industry leading ideas from some of the best minds in our field.

  • Virtual Reality & 3D Solutions

    Our clients demand the latest and most effective digital tools in the delivery of our designs.

  • Laboratories

    Intelligent environments and smart processes. Innovative integrated laboratory solutions delivered by our expert engineers, scientists and architects.

  • Construction Management & HSE

    Our robust CM tools and skilled teams enable us to develop specific plans that deliver projects safely and to scope, time and budget.

  • Functional Safety Management

    We ensure our clients meet their regulatory safety obligations. We offer complete lifecycle functional management; bringing process and operational expertise together with the latest analysis tools.

  • Technology Transfer & Scale-up

    We design and incorporate innovative processes that can be scaled up or easily transferred to other locations.

  • Asset Lifecycle Management

    We support our clients in managing their facilities and deliver operational savings in their work processes, from installation through to decommissioning.

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