GxP Compliance Services

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GxP Compliance Services

Our experts have in-depth knowledge in all GxP areas and support you in complying with regulatory requirements relating to cGMP activities through targeted quality management. From document creation for risk-based C&Q, validation of cleaning and manufacturing processes through to routine production. In addition, we provide support in the areas of training on GMP aspects, audits, supplier qualification and regulatory affairs and the development of quality management systems.

We can also support your existing quality systems and accompany you throughout the entire product life cycle. Morgan Sindall stands for comprehensive end-to-end compliance.

Services

  • QA for supplier and CMO management
  • Onboarding and training organisation (internal and external)
  • QA during all stages of the product lifecycle
  • Project processes standardisation
  • Qualification processes standardisation
  • Development and support of quality management systems
  • QA according to regulatory requirements (e.g. cGMP / ICH / 21 CFR) and valid guidelines (ISO, SHE, ASTM, ISPE) in the technical as well as operational area
  • QA for the aseptic and non-aseptic production of biological and chemical active ingredients and excipients as well as pharmaceuticals
  • Qualification of contractors / suppliers
  • QA Risk and Gap Analyses
  • Processing of compliance deviations, CAPA and change management
  • QA management of transfer projects
  • Specialists for Regulatory Affairs

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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.

  • 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.

  • Modernisation of API production building

    Our customer, a leading pharmaceutical manufacturer needed a state-of -the-art manufacturing plant for their new blockbuster blood pressure product.

Further Capabilities

  • 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.

  • Virtual Reality & 3D Solutions

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

  • Process Engineering

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

  • Laboratories

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

  • Building Services

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

  • 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.

  • 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.

  • Technology Transfer & Scale-up

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

  • CQV Services

    We support our clients with efficient commissioning, qualification and validation activities and ensure a punctual system handover for a successful start-up.

  • Responsible Person / Qualified Person & Regulatory Affairs

    We offer efficient support through our FvPs/QPs, Quality and Regulatory Affairs managers in the areas of GMP and GDP.

  • 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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