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Our Services

Welcome to our comprehensive range of tailored Quality Management and Compliance Services, with personalised support we're committed to helping your company to achieve and maintain the highest standards of Quality, Regulatory Compliance, and operational excellence.

We provide end-to-end technical consultancy and business support, from receipt to release. Our services cover:

  • Quality Management Systems (QMS): Design, implementation, and optimization of robust QMS aligned with global regulatory requirements.
  • Regulatory Compliance: Guidance and support to meet international regulatory requirements like EMA and FDA, standards, ensuring your products and processes remain audit-ready.
  • Risk Management & Governance: Comprehensive risk assessments and governance frameworks to safeguard product integrity and patient safety.
  • Training & Continuous Improvement: Tailored programs to empower your teams and drive sustainable compliance culture in a wide range of topics.


Quality

  • Development & optimization of Quality Management System

  • Quality Risk Management

    • Risk Assessments
    • Gap Assessments

  • Conceptual review of

    • facilities
    • utilities
    • equipment
    • RABS
    • Isolators

Management 

  • Interim Quality Management

  • Remediation Plan

    • Development
    • Implementation
  • Deviations & CAPAs
  • Internal audits

  • Vendor Management

    • Program development
    • Vendor audits

Compliance

  • Inspection readiness & remediation
  • Mock inspections
  • Facility design
  • Contamination Control
  • Bespoke GMP training and coaching
  • Technical training

  • Performance qualification of:

    • Cleanrooms
    • Utilities
    • Aseptic processes
    • Cleaning & disinfection programs

Benefits for your company:

  • Regulatory Confidence: Stay informed about evolving regulations and how these apply to your situation. Avoid costly non-compliance issues.
  • Operational Efficiency: Streamlined processes reduce errors, improve quality, improve productivity, and lower costs.
  • Risk Mitigation: Proactive identification and management of risks to protect your product.
  • Expert Partnership: Access to experienced consultants with decades of deep industry knowledge and proven track records.

Partnering with us means peace of mind, improved performance, and a competitive edge in a highly regulated industry.
We are not only able to identify areas for improvement, we can help you implementing the solutions.

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