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CTG’s GxP Compliance Services support companies within the healthcare and life sciences industries to ensure their products are safe for use.

Whether you are a start-up company in need of professional expertise to set up and implement a business model for Quality, Validation, and Compliance, or a global life sciences company in need of resources to execute and manage validation and compliance projects, CTG’s Regulatory Compliance consultants are fully equipped to get the job done and satisfy your expectations.

Our services are based on lean, scalable and risk-based concepts, and designed using industry best practices.

That’s why CTG developed GxP Compliance Services

Our offerings enable clients to achieve and maintain their regulatory compliance objectives by providing a range of services in multidisciplinary environments like IT, Compliance, Risk, QA, and other.

  • Ctg Icon Performance

    Enhancement of Process of Supplier Approval/Rejection

  • Ctg Icon Risk

    Successful FDA and EU Inspections

  • Ctg Icon Operations

    Compliance with GaMP 5 Expectations and Guidelines

  • Ctg Icon Advantage

    Significant Reduction of Vaidation Time Effort and Cost

  • Ctg Icon Safety

    Cost Savings due to Process Improvements and Standardization

  • Ctg Icon Security

    Minimization of Risks such as Data Loss or Corrupted Data

  • Ctg Icon Webinar Transcript

    Delivery of Ready-to-Use, Correct, Secure and Compliant Spreadsheets

INTRODUCING CTG’S

GxP Services

Patient safety is paramount when performing clinical studies or using pharmaceutical products or medical devices. By applying Good Practices (GxP) quality guidelines and regulations, companies within the healthcare and life sciences industries can ensure their products are safe to use.

CTG’s approach on GxP compliance

To accommodate your organization to meet GxP compliance, we offer a variety of GxP Compliance Services. These services are based on lean, scalable, risk-based, and agile concepts, all following the latest standards in the market.

  • Ctg Icon Process

    Agile Computer System Validation

    Ensures the validated state of your entire system

    • Risk based
    • Scalable
    • Lean
    • Successful FDA and EU inspections
    • Significant reduction of validation time, effort and cost
    • On-call assistance during inspections
  • Ctg Icon Storage

    ERP/SAP Validation

    Leverages ERP/SAP knowledge and documentation to enhance validation

    • Excellent Baseline based on SAP specific supporting processes
    • Successful FDA and EU inspections
    • Significant reduction of validation time, effort and cost
    • On-call assistance during inspections
  • Ctg Icon Analytics

    Outsourced Spreadsheet Validation

    Takes full ownership of the validation of your spreadsheets.

    • Successful FDA and EU inspections
    • Ready-to-use, correct, secure and compliant spreadsheets
    • No validation effort is required from your part
  • Ctg Icon Value Forward

    Agile Development & Computerized System Validation

    Ensures the validated state of agile developed applications.

    • Time and cost savings due to process improvements and standardization
    • Meet GaMP 5 expectations
  • Ctg Icon Security

    IT Infrastructure Qualification

    Realizes a secure and easily maintainable IT infrastructure.

    • Increase of transparency and efficiency
    • Cost savings due to process improvements and standardization
    • Minimizes risks such as data loss, corrupted data to an acceptable level
  • Ctg Icon Safety

    Compliance Assessment and Remediation

    Provides a detailed picture of compliance gaps and remediation measures.

    • An Assessment Report to enable monitoring of the remediation effort
    • Ready-to-go Roadmap for Remediation
  • Ctg Icon Webinar Slides

    Vendor Audit

    Identifies the risks that can impact your business.

    • Enhancing process of supplier approval/rejection
    • Audit Report to enable you to monitor the remediation effort with your supplier
  • Ctg Icon Technology

    Equipment Qualification

    Qualifies a wide range of your laboratory equipment

    • Experienced Subject Matter Experts on all types of equipment
    • Deliver equipment that is qualified according to current best practices and regulatory requirements
    • Free of charge after care within a year
  • Ctg Icon Webinar Video

    Training and Coaching

    Helps your organization get a better understanding of compliance topics.

    • Increase in effectiveness and efficiency
    • High ROI
    • Training that is tailored to your specific business needs

View our GxP overview collateral for more information about how CTG can help you in your validation and compliance projects.

View Collateral

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