Are you hooked on Compliance?

GMP, ICH and ISO rules rigorous respecting, equipment deep knowledge, strong experience in validation and qualification activites, Project Management skills, ability to listen and give support, passion for our job. These are the main reasons why our Clients chose our consulting services to increase compliance and offer safer and more effective products.

You can always rely on S4BT’s know how: a real network of backgrounds and skills.

  • Study of the context and specifics
  • Detailed needs analysis
  • Specific solutions identification
will guarantee the best team for the job.

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Most relevant Services

Validation

  • Cleaning Validation
  • Process Validation
  • Packaging Validation
  • Shipping Validation
  • Thermal Mapping
  • Validation Service

QA & Compliance

  • Deviation Management & CAPA
  • Change Control Management
  • Complaint Management
  • External & Internal Audit Support
  • Training Documentation Management
  • Quality Monitoring
  • Batch Record Review
  • Data & Workflow Management
  • Risk Management

IT & CSV

  • Network Infrastructure Qualification
    • Computer System Validation
      • Data Integrity
      • Gap Analysis CFR 21 part 11/EU Annex 11
      • Supplier Software Selection
        • Drafting of administrative SOP
        • Regular Audit Trail Review

        Quality Control

        • Chemical Analysis Support
        • Microbiological Analysisi Support
        • Analytical Method Development
        • Analytical Method Validation
        • Stability Studies
        • Analytical Troubleshooting
        • QC Documentation Support

        Engineering & Qualification

        • Equipment Qualification
        • Commissioning
        • Revamping Areas/Equipment
        • Qualification of Controlled Contamination Environments & Equipment
        • HVAC Qualification
        • Water System Qualification
        • Utilities Qualification
        • Warehouse Qualififcation
        • Controlled Temperature and Humidity Environment Qualififcation
        • Engineering Studies
        • Regular Requalification

        Project Management

        • Project Start up
        • Cross Multifunctional Team Management
        • Time & Cost Management
        • Communication MManagement
        • WBS Creation & Management
        • Project Charter & Risk Register
        • KPI Monitoring

        New Product Introduction

        • Design of Experiment Studies
        • Feasibility Studies

        Technology Transfer

        • E2E Product Transfer Management
        • Technical Support during Technology Transfer/Localisation Project





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