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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Further Capabilities

  • Laboratories

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

  • 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.

  • 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.

  • 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.

  • Building Services

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

  • Facility Design

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

  • 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.

  • CQV Services

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

  • 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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