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.

  • Process

    Enhancement of Process of Supplier Approval/Rejection

  • Certify

    Successful FDA and EU Inspections

  • Testing

    Compliance with GaMP 5 Expectations and Guidelines

  • Decline

    Significant Reduction of Vaidation Time Effort and Cost

  • Revenue Efficiency

    Cost Savings due to Process Improvements and Standardisation

  • Risk

    Minimisation of Risks such as Data Loss or Corrupted Data

  • Blog/Report

    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 organisation 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.

  • Testing Assess

    Computerised System Validation (CSV)

    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
  • Usability

    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
  • Software

    CSV Supporting Agile Development Methods

    Ensures the validated state of agile-developed applications.

    • Time and cost savings due to process improvements and standardisation
    • Meet GaMP 5 expectations
  • Collateral/Reports

    Spreadsheet Validation as a Service

    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
  • Man Gear

    Quality Coaching as a Service

    Offers immediate assistance to address specific GxP and/or ISO 27001 related requests.

    • GxP/ISO 27001 help desk
  • Training Education

    Training and Coaching

    Helps your organisation get a better understanding of compliance topics.

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

    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
  • Assessment/Envisioning

    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
  • Security

    IT Infrastructure Qualification

    Realises a secure and easily maintainable IT infrastructure.

    • Increase of transparency and efficiency
    • Cost savings due to process improvements and standardisation
    • Minimises risks such as data loss, corrupted data to an acceptable level
  • Technology Industry

    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

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

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Looking for more information about CTG's Quality Coaching as a service? View our collateral now to learn more.

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